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Wellkang Ltd

Authorized Representative in the United Kingdom

Enterprise Hub, NW Business Complex 1 Beraghmore Road

Derry, Northern Ireland, Northern Ireland, United Kingdom

Postcode: BT48 8SE

Relationship Type: Authorised Representative (Northern Ireland)
1454 Products Represented
243 Manufacturers
Total Products
1454
Manufacturers
243
Device Types
2
Generic Names
1019
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (1454)
Complete portfolio registered with MHRA

Calreticulin (CALR) gene mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Stockinette

Manufacturer:

RAFFIN MEDICAL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Rubbercare Protection Products Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Finger/hand exerciser

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam clamp forceps

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam kit

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrode conductive medium

Manufacturer:

Kustomer Kinetics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Finger/hand exerciser

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam clamp forceps

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam, non-latex

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Disposable surgical irrigation/aspiration system

Manufacturer:

Beijing Wanjie Medical Device Corporation Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical irrigation/aspiration tubing set

Manufacturer:

Beijing Wanjie Medical Device Corporation Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic video image processing unit

Manufacturer:

MacroLux Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible video bronchoscope, single-use

Manufacturer:

MacroLux Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid video hysteroscope

Manufacturer:

MacroLux Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic video image processing unit

Manufacturer:

MacroLux Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible video cystoscope, single-use

Manufacturer:

MacroLux Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Back/leg/chest dynamometer, electronic

Manufacturer:

Meloq AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Inspiratory line humidification chamber, reusable

Manufacturer:

Wuxi Jike Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Abdominal binder, reusable

Manufacturer:

Zhejiang Rehan Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cervical spine collar, reusable

Manufacturer:

Zhejiang Rehan Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Finger/hand exerciser

Manufacturer:

Zhejiang Rehan Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee immobilizer

Manufacturer:

Zhejiang Rehan Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rib/sternum binder, single-use

Manufacturer:

Zhejiang Rehan Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Shoulder immobilizer/orthosis, reusable

Manufacturer:

Zhejiang Rehan Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tubular support bandage, Hevea-latex

Manufacturer:

Zhejiang Rehan Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tubular support bandage, non-latex, reusable

Manufacturer:

Zhejiang Rehan Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Raised toilet seat

Manufacturer:

Zhongshan First Medical Equipment Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical soft-tissue manipulation forceps, scissors-like, reusable

Manufacturer:

ZIEN Medical Technologies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical system generator

Manufacturer:

Baisheng Medical Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Video capsule endoscopy system monitor

Manufacturer:

ANKON Technologies Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic bracket, metal

Manufacturer:

Astar Orthodontics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laparoscopic trocar blade, single-use

Manufacturer:

Baisheng Medical Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stationary oxygen concentrator

Manufacturer:

BMC Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

CPAP/BPAP face mask, reusable

Manufacturer:

BMC Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

CPAP/BPAP face mask, single-use

Manufacturer:

BMC Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

CPAP/BPAP face mask, single-use

Manufacturer:

BMC Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

CPAP/BPAP nasal mask, reusable

Manufacturer:

BMC Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

CPAP/BPAP nasal mask, reusable

Manufacturer:

BMC Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cranial bur, single-use

Manufacturer:

Chongqing Xishan Science & Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic soft-tissue release system blade

Manufacturer:

Chongqing Xishan Science & Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Metal/carbide ENT bur, single-use

Manufacturer:

Chongqing Xishan Science & Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-purpose surgical power tool system, line-powered

Manufacturer:

Chongqing Xishan Science & Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual endodontic file/rasp, single-use

Manufacturer:

DongGuan LinSky Medical Device Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Continuous electronic patient thermometer, battery-powered

Manufacturer:

Dongguan SIMZO Electronic Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, ear/skin

Manufacturer:

Dongguan SIMZO Electronic Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Benchtop nebulizer, non-heated

Manufacturer:

Foshan Gaunying Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Air-conduction hearing aid, in-the-ear

Manufacturer:

Foshan Vohom Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental delivery system instrument unit, electric

Manufacturer:

Foshan Roson Medical Intruments Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Metal medicine container

Manufacturer:

Ningbo High-Tech Bluesky Manufactory & Trading Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral angioplasty balloon catheter, basic

Manufacturer:

Princetion Medical Scientific Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular microcatheter

Manufacturer:

Princetion Medical Scientific Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Manufacturer:

Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Manufacturer:

Shenzhen Finicare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, ear/skin

Manufacturer:

Shenzhen Finicare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rotary/reciprocating endodontic file/rasp, single-use

Manufacturer:

Shenzhen Denco Medical Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Manufacturer:

Shenzhen Hingmed Medical Instrument Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood pressure ambulatory recorder

Manufacturer:

Shenzhen Hingmed Medical Instrument Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, ear/skin

Manufacturer:

Shenzhen Pacom Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Manufacturer:

Shenzhen Ruiankang Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Home CPAP unit

Manufacturer:

Shenzhen SunnyGrand Healthcare Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Manufacturer:

Shenzhen Urion Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Manufacturer:

Shenzhen Urion Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, ear/skin

Manufacturer:

Shenzhen Urion Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Natural gutta-percha

Manufacturer:

Shenzhen Superline Technology Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Manufacturer:

ShenZhen ZhengKang Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Home CPAP unit

Manufacturer:

Shenzhen SunnyGrand Healthcare Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic electrosurgical electrode, bipolar, single-use

Manufacturer:

SIMAI Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic video image processing unit

Manufacturer:

SIMAI Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Resectoscope

Manufacturer:

SIMAI Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatological diode laser system

Manufacturer:

Beijing Sincoheren Science and Technology Development Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatological frequency-doubled solid-state laser system

Manufacturer:

Beijing Sincoheren Science and Technology Development Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatological carbon dioxide laser system

Manufacturer:

Beijing Sincoheren Science and Technology Development Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External counterpulsation system, stationary

Manufacturer:

Chongqing PSK-Health Sci-Tech Development Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood washing/centrifugation bag

Manufacturer:

Innvol Medical India Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemoperfusion system absorption column

Manufacturer:

Jafron Biomedical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Memory-alloy patella fixation grip

Manufacturer:

Lanzhou Seemine SMA Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Plant polysaccharide haemostatic agent, bioabsorbable

Manufacturer:

LifeScience PLUS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Amies transport medium IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Arterial tourniquet, manual, single-use

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Assay container IVD, single-use

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay container IVD, single-use

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Blood smearing manual instrument IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Centrifuge tube IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal specimen container IVD, transport buffer/medium

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General laboratory container, reusable

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General specimen container IVD, no additive/medium

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen microscopy slide IVD, single-use

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General-purpose absorbent tip applicator/swab, single-use

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Inoculating tool IVD, manual

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Instrument/analyser specimen/reagent container carrier IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microbial cryotube IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide coverslip IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide holder, preparation/staining

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Microtome blade IVD, reusable

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General-purpose medical fibre padding

Manufacturer:

Naturs Design, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, skin

Manufacturer:

Netop Industrial Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal phototherapy system

Manufacturer:

Netop Industrial Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal phototherapy system

Manufacturer:

Netop Industrial Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Otoscope, direct

Manufacturer:

Netop Industrial Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood collection tube holder, single-use

Manufacturer:

Merah Medical Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood collection tube holder, single-use

Manufacturer:

Merah Medical Sdn Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eyelid solution

Manufacturer:

The Hilsinger Company Parent, LLC dba Bruder Healthcare

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hot/cold therapy pack, reusable

Manufacturer:

The Hilsinger Company Parent, LLC dba Bruder Healthcare

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Image segmentation application software

Manufacturer:

Three Palm Software

Type:

General Medical Device

Registration Date:

Nov 26, 2024

PEEP valve, reusable

Manufacturer:

THREE LIONS LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pulmonary resuscitator, manual, single-use

Manufacturer:

THREE LIONS LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Reinforced laryngeal mask airway, reusable

Manufacturer:

THREE LIONS LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Reinforced laryngeal mask airway, single-use

Manufacturer:

THREE LIONS LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Glucose monitoring system IVD, home-use

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyser IVD, home-use

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Biomate Medical Devices Technology Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heel protector

Manufacturer:

Walgreen Health Solutions, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anaesthesia face mask, single-use

Manufacturer:

Omnimate Enterprise Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Emergency airway clearance suction system, manual

Manufacturer:

Omnimate Enterprise Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental mirror, reusable

Manufacturer:

Surgistar Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic irrigation/infusion/aspiration cannula, illuminating, single-use

Manufacturer:

Surgistar Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic knife, single-use

Manufacturer:

Surgistar Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic sponge

Manufacturer:

Surgistar Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel handle, reusable

Manufacturer:

Surgistar Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical eye pressure shield

Manufacturer:

Surgistar Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic examination slit lamp

Manufacturer:

Suzhou Microclear Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic fundus camera

Manufacturer:

Suzhou Microclear Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heat/moisture exchanger, single-use

Manufacturer:

Great Group Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Inspiratory line humidification chamber, single-use

Manufacturer:

Great Group Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neonatal high-flow respiratory unit

Manufacturer:

Great Group Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Professional high-flow respiratory unit, humidifying

Manufacturer:

Great Group Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental chair, electric

Manufacturer:

Guangzhou Fengdan Medical Equipment Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Decorative contact lens, daily-wear

Manufacturer:

HaiChang Contact Lens Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyester suture, non-bioabsorbable, multifilament

Manufacturer:

HuaiYin Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyolefin/fluoropolymer suture, monofilament

Manufacturer:

HuaiYin Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel, single-use

Manufacturer:

HuaiYin Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical retractor/retraction system blade, single-use

Manufacturer:

HuaiYin Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

CPAP/BPAP face mask, reusable

Manufacturer:

Hunan Beyond Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Root canal post, preformed

Manufacturer:

iLumi Sciences Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Angiography kit

Manufacturer:

Jiangxi BaoErAn BioMedical Science & Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Autotransfusion system blood component processing set

Manufacturer:

Jiangxi BaoErAn BioMedical Science & Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin-cleaning wipe, sterile

Manufacturer:

Lights Medical Manufacture Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Analgesic transcutaneous electrical nerve stimulation system

Manufacturer:

Netop Industrial Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Alpha-fetoprotein (AFP) IVD, kit, rapid ICT, clinical

Manufacturer:

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD, manual

Manufacturer:

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, kit, rapid ICT, clinical

Manufacturer:

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ferritin IVD, kit, rapid ICT, self-testing

Manufacturer:

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple anti-neutrophil cytoplasmic antibody/glomerular basement membrane antibody IVD, kit, fluorescent immunoassay

Manufacturer:

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid stimulating hormone (TSH) IVD, kit, rapid ICT, clinical

Manufacturer:

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Scanning-laser retinal imaging system

Manufacturer:

Suzhou Microclear Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External ocular measurement camera

Manufacturer:

Suzhou Microclear Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic fundus camera

Manufacturer:

Suzhou Microclear Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scanning-laser ophthalmic imaging system

Manufacturer:

Suzhou Microclear Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, ear

Manufacturer:

Netop Industrial Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, ear/skin

Manufacturer:

Netop Industrial Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal phototherapy system

Manufacturer:

Netop Industrial Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Perineal orifice incontinence-control electrical stimulation system, home-use

Manufacturer:

Netop Industrial Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Red/blue light phototherapy unit

Manufacturer:

Netop Industrial Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urinary-incontinence vaginal insert, reusable

Manufacturer:

Netop Industrial Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiopulmonary resuscitation mask, single-use

Manufacturer:

Omnimate Enterprise Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laryngeal mask airway, single-use

Manufacturer:

Omnimate Enterprise Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Freestanding patient lifting system, electrically-powered

Manufacturer:

Opitek International

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Leg procedure positioner

Manufacturer:

Opitek International

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Leg sling

Manufacturer:

Opitek International

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vision training software

Manufacturer:

Guangzhou Shijing Medical Software Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical gown, single-use

Manufacturer:

Haian Medigauze Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Penile vacuum device

Manufacturer:

BonRoux Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/medical face mask, single-use

Manufacturer:

BYD Precision Manufacture Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Inspiratory line humidification chamber, single-use

Manufacturer:

Oxytek Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Microbiological transport medium IVD

Manufacturer:

Merah Medical Sdn Bhd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ice bag

Manufacturer:

The Hilsinger Company Parent, LLC dba Bruder Healthcare

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiology DICOM image processing application software

Manufacturer:

Three Palm Software

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anaesthesia breathing circuit, single-use

Manufacturer:

THREE LIONS LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anaesthesia face mask, single-use

Manufacturer:

THREE LIONS LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endotracheal tube guide, single-use

Manufacturer:

THREE LIONS LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laryngeal mask airway, reusable

Manufacturer:

THREE LIONS LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laryngeal mask airway, single-use

Manufacturer:

THREE LIONS LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasopharyngeal airway, single-use

Manufacturer:

THREE LIONS LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

PEEP valve, single-use

Manufacturer:

THREE LIONS LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Resuscitator face mask, single-use

Manufacturer:

THREE LIONS LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal oxygen cannula, basic

Manufacturer:

Great Group Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Decorative contact lens, daily-disposable

Manufacturer:

HaiChang Contact Lens Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-purpose soft contact lens solution

Manufacturer:

HaiChang Contact Lens Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Soft corrective contact lens, daily-disposable

Manufacturer:

HaiChang Contact Lens Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Metallic suture, multifilament

Manufacturer:

HuaiYin Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyester suture, non-bioabsorbable, multifilament

Manufacturer:

HuaiYin Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyolefin/fluoropolymer suture, monofilament

Manufacturer:

HuaiYin Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scalpel, single-use

Manufacturer:

HuaiYin Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Silk suture

Manufacturer:

HuaiYin Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Silk suture

Manufacturer:

HuaiYin Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rotary/reciprocating endodontic file/rasp, single-use

Manufacturer:

Huizhou Videya Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

CPAP/BPAP nasal mask, reusable

Manufacturer:

Hunan Beyond Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracic electrical bioimpedance system, tomographic

Manufacturer:

Infivision Medical Imaging Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound drainage kit

Manufacturer:

International Medical Research Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Custom-made dental crown, metal/polymer

Manufacturer:

Shenzhen New Perfect Exact Dental Research Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental bridge, ceramic

Manufacturer:

Shenzhen New Perfect Exact Dental Research Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental bridge, metal-ceramic

Manufacturer:

Shenzhen New Perfect Exact Dental Research Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic progressive aligner

Manufacturer:

Shenzhen New Perfect Exact Dental Research Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hepatitis B virus surface antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Core Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus total antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Core Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Core Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing

Manufacturer:

Core Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Electrocardiographic lead set, reusable

Manufacturer:

Huizhou Carefit Medical Electronic Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Glucose IVD, control

Manufacturer:

AEON DIAGNOSTIC Technology Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing

Manufacturer:

Abiores Technology (Beijing) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose rapid test/blood pressure system analyser, home-use

Manufacturer:

Abiores Technology (Beijing) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing

Manufacturer:

Abiores Technology (Beijing) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

Manufacturer:

Abiores Technology (Beijing) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Biotech India Limited (a subsidiary of Kilpest India Limited)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dihydropyrimidine dehydrogenase (DPYD) gene polymorphism IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Biotech India Limited (a subsidiary of Kilpest India Limited)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple immunocompromised host infection-associated virus nucleic acid IVD, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Biotech India Limited (a subsidiary of Kilpest India Limited)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

3B BlackBio Biotech India Limited (a subsidiary of Kilpest India Limited)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thiopurine S-methyltransferase (TPMT) gene polymorphism IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Biotech India Limited (a subsidiary of Kilpest India Limited)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Careglove Global SDN BHD

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex surgical glove, powdered

Manufacturer:

Careglove Global SDN BHD

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrile examination/treatment glove, powdered

Manufacturer:

Careglove Global SDN BHD

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Careplus (M) Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cotton wool roll, sterile

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental articulation paper

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental mirror, single-use

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-woven gauze pad

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Root canal irrigation blunt needle

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acute myeloid leukaemia (AML) genetic mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anaplastic lymphoma kinase (ALK) genetic mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ankylosing spondylitis IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

BRAF V600 gene mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Absorbent underpad, non-antimicrobial, single-use

Manufacturer:

RAFFIN MEDICAL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dihydropyrimidine dehydrogenase (DPYD) gene polymorphism IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

JAK2 V617F gene mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

KIT gene mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Leukaemia-associated fusion gene IVD, control

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microbiological transport medium IVD

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple immunocompromised host infection-associated virus nucleic acid IVD, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Leptospira species nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple urinary tract infection-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type meningitis pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycobacterium tuberculosis nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Philadelphia chromosome/BCR-ABL mRNA expression IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Plasmodium malariae nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

ROS proto-oncogene 1 receptor tyrosine kinase gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD127 cell marker IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD28 cell marker IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD4 cell marker IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD45 leukocyte common antigen cell marker IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD8 cell marker IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Chengdu IXING Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Biotech India Limited (a subsidiary of Kilpest India Limited)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Biotech India Limited (a subsidiary of Kilpest India Limited)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

B-cell acute lymphoblastic leukaemia (B-ALL) genetic mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Isocitrate dehydrogenase 1/isocitrate dehydrogenase 2 (IDH1/IDH2) gene mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multidrug-resistant nontuberculous Mycobacterium (NTM) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Aspergillus species nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple respiratory disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Salmonella species nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myeloproliferative neoplasm-associated multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

NRAS gene mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Orientia tsutsugamushi nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parvovirus B19 nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

PIK3CA gene mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Toxoplasma gondii nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Zika virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD117 (c-kit) cell marker IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD14 cell marker IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD20 cell marker IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD38 cell marker IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD45RA cell marker IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD69 cell marker IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD7 cell marker IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

Manufacturer:

Chengdu IXING Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

Manufacturer:

Chengdu IXING Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

Chengdu IXING Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, reagent

Manufacturer:

Chengdu IXING Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Custom-made dental crown, metal

Manufacturer:

Shenzhen New Perfect Exact Dental Research Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Partial denture

Manufacturer:

Shenzhen New Perfect Exact Dental Research Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic electrode, reusable

Manufacturer:

Huizhou Carefit Medical Electronic Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic electrode, reusable

Manufacturer:

Huizhou Carefit Medical Electronic Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic lead set, reusable

Manufacturer:

Huizhou Carefit Medical Electronic Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Glucose IVD, kit, electrometry

Manufacturer:

AEON DIAGNOSTIC Technology Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Abiores Technology (Beijing) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Abiores Technology (Beijing) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nasal irrigation saline solution

Manufacturer:

Halosense Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Evacuated blood collection tube IVD, anticoagulant

Manufacturer:

ShenZhen BoomingShing Medical Device Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hevea-latex examination/treatment glove, powdered

Manufacturer:

Careglove Global SDN BHD

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Careglove Global SDN BHD

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Careplus (M) Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental cotton roll

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic instrument chairside holder set

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hypodermic needle, single-use

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dappen dish, single-use

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental anaesthesia syringe/needle

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental cotton roll

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material application tool, single-use

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Digital imaging cassette/storage phosphor screen, dental

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic instrument chairside holder set

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument tray cover, single-use

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Woven gauze pad

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/surgical polymerization lamp

Manufacturer:

Guangzhou RebornEndo Medical instrument Co,. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic apex locator

Manufacturer:

Guangzhou RebornEndo Medical instrument Co,. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixed examination/treatment room light

Manufacturer:

Burton Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nucleic acid sequence analyser IVD, Sanger sequencing

Manufacturer:

BYD Precision Manufacture Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatine?kinase?myocardial?isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay

Manufacturer:

MEDCAPTAIN Medical Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, kit, chemiluminescent immunoassay

Manufacturer:

MEDCAPTAIN Medical Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interleukin-6 (IL-6) IVD, control

Manufacturer:

MEDCAPTAIN Medical Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoglobin IVD, kit, chemiluminescent immunoassay

Manufacturer:

MEDCAPTAIN Medical Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, control

Manufacturer:

MEDCAPTAIN Medical Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cryptococcus complex species antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Nanjing Liming Bio-Products Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen collection kit IVD, clinical

Manufacturer:

Nanjing Liming Bio-Products Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Candida antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Nanjing Liming Bio-Products Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 total/neutralizing antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Nanjing Liming Bio-Products Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

Manufacturer:

Prometheus Bio Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

Manufacturer:

Prometheus Bio Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Manufacturer:

Prometheus Bio Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Prometheus Bio Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adenovirus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Safecare Biotech (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mitragynine IVD, kit, rapid ICT, clinical

Manufacturer:

Safecare Biotech (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, kit, rapid ICT, clinical

Manufacturer:

Safecare Biotech (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoglobin IVD, kit, rapid ICT, clinical

Manufacturer:

Safecare Biotech (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rotavirus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Safecare Biotech (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Salmonella typhi antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Safecare Biotech (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vibrio cholerae antigen (multiple serotype) IVD, kit, rapid ICT, clinical

Manufacturer:

Safecare Biotech (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatine?kinase?myocardial?isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Estradiol?(oestradiol) (E2) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoglobin IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Progesterone IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prolactin IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total estriol (oestriol) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total testosterone IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multichannel clinical chemistry analyser IVD, home-use, line-powered

Manufacturer:

Shenzhen Tailored Medical Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, rapid ICT, clinical

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, kit, rapid ICT, clinical

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, kit, rapid ICT, clinical

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multichannel clinical chemistry analyser IVD, point-of-care, line-powered

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myeloperoxidase (MPO) IVD, reagent

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoglobin IVD, kit, rapid ICT, clinical

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neopterin IVD, reagent

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Single-channel clinical chemistry analyser IVD, point-of-care

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin I IVD, kit, rapid ICT, clinical

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dental/surgical polymerization lamp

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Glucose analyser IVD, home-use

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haematological cell analyser IVD

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haemoglobin analyser IVD, laboratory

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haemoglobin detection IVD, reagent

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Reticulocyte count IVD, control

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Intravenous access site protector

Manufacturer:

I.V. House, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee support orthosis

Manufacturer:

POD Active Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medicine cup, single-use

Manufacturer:

Precispharma Containers Private Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Interferon gamma release IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Hainan VTI Clinical Immunology Lab Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Kangmei Tianhong Biotech (Beijing) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2/influenza A/B nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Kangmei Tianhong Biotech (Beijing) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Carcinoembryonic antigen (CEA) IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple anticonvulsant therapeutic drug monitoring IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytology specimen container IVD, transport buffer

Manufacturer:

Heng Rong (Xiamen) Plastic Products Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Electrocardiographic electrode, single-use

Manufacturer:

Dongguan Quanding Medical Supplies Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/medical face mask, single-use

Manufacturer:

Dongguan Quanding Medical Supplies Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment handle cover, single-use

Manufacturer:

Dongguan Senmed Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical sponge-counting bag

Manufacturer:

Dongguan Senmed Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Incentive spirometer

Manufacturer:

e-LinkCare Meditech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medicine chamber spacer, reusable

Manufacturer:

e-LinkCare Meditech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyser IVD, home-use

Manufacturer:

e-LinkCare Meditech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyte monitoring system IVD, point-of-care

Manufacturer:

e-LinkCare Meditech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Spirometry/pulmonary function pressure tube

Manufacturer:

e-LinkCare Meditech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Video capsule endoscopy system monitor

Manufacturer:

ANKON Technologies Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound/centesis drainage receptacle

Manufacturer:

Apex (Guangzhou) Tools & Orthopedics Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Disposable surgical irrigation/aspiration system

Manufacturer:

Apex (Guangzhou) Tools & Orthopedics Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone pin, non-bioabsorbable

Manufacturer:

Apex (Guangzhou) Tools & Orthopedics Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical irrigation system nozzle

Manufacturer:

Apex (Guangzhou) Tools & Orthopedics Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multiple vital physiological parameter monitoring system, clinical

Manufacturer:

APK Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Assistive syringe dose dispenser

Manufacturer:

Acute Ideas Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

1,3-Beta-D-glucan IVD, kit, enzyme spectrophotometry

Manufacturer:

Dynamiker Biotechnology (Tianjin) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Candida albicans immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Dynamiker Biotechnology (Tianjin) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Candida species mannan antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Dynamiker Biotechnology (Tianjin) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Monkeypox virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Dynamiker Biotechnology (Tianjin) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multichannel immunoassay analyser IVD

Manufacturer:

Dynamiker Biotechnology (Tianjin) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Incontinence penis clamp, reusable

Manufacturer:

Cross Innovations LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood smearing manual instrument IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cell culture line IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal specimen container IVD, transport buffer/medium

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen container IVD, no additive/medium

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen microscopy slide IVD, single-use

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General-purpose absorbent tip applicator/swab, single-use

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose absorbent tip applicator/swab, single-use

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument/analyser specimen/reagent container carrier IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Specimen transfer scooping tool IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antiseptic swab

Manufacturer:

Jianerkang Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cotton wool roll, sterile

Manufacturer:

Jianerkang Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose surgical sponge

Manufacturer:

Jianerkang Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose surgical sponge

Manufacturer:

Jianerkang Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-woven gauze pad

Manufacturer:

Jianerkang Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiopaque woven surgical sponge

Manufacturer:

Jianerkang Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin-cleaning wipe, sterile

Manufacturer:

Jianerkang Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical scrub brush, single-use

Manufacturer:

Jianerkang Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Woven gauze pad

Manufacturer:

Jianerkang Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spectacle frame

Manufacturer:

Jiangsu East Optics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastro-urological guidewire, single-use

Manufacturer:

Jiangsu Changmei Medtech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Kyphoplasty balloon catheter

Manufacturer:

Jiangsu Changmei Medtech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flatus tube, single-use

Manufacturer:

Cotronic Technology Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal irrigation applicator

Manufacturer:

Cotronic Technology Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Beijing USCI Medical Devices Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Surgical/medical face mask, non-antimicrobial, single-use

Manufacturer:

Ataraxis Medical Supply Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Finger/hand exerciser

Manufacturer:

ELASTOMADE ACCESSORIES SDN. BHD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam, Hevea-latex

Manufacturer:

ELASTOMADE ACCESSORIES SDN. BHD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External limb prosthesis finishing component, non-customized

Manufacturer:

Embreis AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External lower-limb prosthesis suspensory component, non-powered

Manufacturer:

Embreis AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic manual linear cutting stapler, single-use

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laparoscopic access cannula, single-use

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laparoscopic access cannula, single-use

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery manual linear stapler, single-use

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical clip remover, reusable

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tissue extraction bag

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fibreoptic operating light system

Manufacturer:

Fiberoptics Technology Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Head-worn fibreoptic light

Manufacturer:

Fiberoptics Technology Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External defibrillation electrode, paediatric, single-use

Manufacturer:

Dongguan Quanding Medical Supplies Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical staple loading unit, non-cutting

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Angiography kit

Manufacturer:

Shenzhen Boon Medical Supply Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Catheter/overtube balloon inflator, single-use

Manufacturer:

Shenzhen Boon Medical Supply Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Contrast medium injection system syringe

Manufacturer:

Shenzhen Boon Medical Supply Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose syringe/needle

Manufacturer:

Shenzhen Boon Medical Supply Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous administration tubing extension set

Manufacturer:

Shenzhen Boon Medical Supply Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laryngoscope blade, single-use

Manufacturer:

Shenzhen Boon Medical Supply Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-fixed blood collection needle

Manufacturer:

Shenzhen Boon Medical Supply Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiographic procedure tubing

Manufacturer:

Shenzhen Boon Medical Supply Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic lead set, reusable

Manufacturer:

Shenzhen Changke Connect Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood pressure cuff, reusable

Manufacturer:

Shenzhen Changke Connect Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic lead set, single-use

Manufacturer:

Shenzhen Changke Connect Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neurophysiologic monitoring system

Manufacturer:

Shenzhen Changke Connect Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Video intubation laryngoscope handle/monitor

Manufacturer:

Shenzhen CoreRay Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

Shenzhen Lontek Electronic Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscope video camera

Manufacturer:

Shenzhen Proxinse Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscope video camera

Manufacturer:

Shenzhen Proxinse Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

MRI system coil, radio-frequency

Manufacturer:

Shenzhen RF Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive strip, reusable

Manufacturer:

Shenzhen SOGA Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental digital imaging sensor, intraoral

Manufacturer:

Shenzhen Xpectvision Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared-light vein locator

Manufacturer:

Shenzhen Yuanray Biomed Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vaginal dilator

Manufacturer:

SoulSource Therapeutic Devices, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cervical cytology brush

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General laboratory container, reusable

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General specimen microscopy slide IVD, single-use

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microplate IVD

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Paraffin-based embedding medium IVD

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pipette rack

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pipette tip IVD

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tissue culture/microbiology petri dish

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose absorbent tip applicator/swab, single-use

Manufacturer:

Medico Technology Co Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Adhesive bandage

Manufacturer:

Bandex Industrial Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Adhesive bandage

Manufacturer:

Bandex Industrial Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dressing-fixation skin adhesive tape, non-silicone

Manufacturer:

Bandex Industrial Corp.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic inter-arch elastic band

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam clamp

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam, non-latex

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Balance ball exerciser

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Body/limb elastic exerciser

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam kit

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam punch

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam, Hevea-latex

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Angiography kit

Manufacturer:

Shenzhen Boon Medical Supply Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiographic procedure tubing

Manufacturer:

Shenzhen Boon Medical Supply Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood pressure cuff, reusable

Manufacturer:

Shenzhen Changke Connect Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose patient temperature probe, single-use

Manufacturer:

Shenzhen Changke Connect Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient monitoring system module, pulse oximetry

Manufacturer:

Shenzhen Changke Connect Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose patient temperature probe, reusable

Manufacturer:

Shenzhen Changke Connect Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pulse oximeter probe, reusable

Manufacturer:

Shenzhen CoreRay Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic video image processing/light source system

Manufacturer:

Shenzhen Proxinse Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/medical face mask, non-antimicrobial, single-use

Manufacturer:

Shenzhen Tsingcare Medical Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/medical face mask, single-use

Manufacturer:

Shenzhen Tsingcare Medical Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical return electrode, single-use

Manufacturer:

Dongguan Quanding Medical Supplies Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment/instrument drape, reusable

Manufacturer:

Dongguan Senmed Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sharps container

Manufacturer:

Dongguan Senmed Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment handle cover, single-use

Manufacturer:

Dongguan Senmed Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sharps container

Manufacturer:

Dongguan Senmed Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrochemical breath analyser IVD, point-of-care

Manufacturer:

e-LinkCare Meditech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose IVD, reagent

Manufacturer:

e-LinkCare Meditech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose/ketone/lipid profile IVD, reagent

Manufacturer:

e-LinkCare Meditech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haemoglobin detection IVD, reagent

Manufacturer:

e-LinkCare Meditech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyte monitoring system IVD, home-use

Manufacturer:

e-LinkCare Meditech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Positive pressure airway secretion-clearing device

Manufacturer:

e-LinkCare Meditech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthotic insole, prefabricated, non-antimicrobial

Manufacturer:

Interpod Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Body/limb elastic exerciser

Manufacturer:

ELASTOMADE ACCESSORIES SDN. BHD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam, Hevea-latex

Manufacturer:

ELASTOMADE ACCESSORIES SDN. BHD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Body/limb elastic exerciser

Manufacturer:

ELASTOMADE ACCESSORIES SDN. BHD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible video ureteroscope, single-use

Manufacturer:

MacroLux Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Clerical marking pen

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General specimen collection kit

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose absorbent tip applicator/swab, single-use

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Histology tissue cassette IVD, laboratory processing, single-use

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inoculating tool IVD, manual

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mechanical micropipette IVD

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide cabinet

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Microscope slide dispenser

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Saliva/oral specimen collection kit, no additive

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/medical face mask, single-use

Manufacturer:

Medico Technology Co Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose absorbent tip applicator/swab, single-use

Manufacturer:

Medico Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Assistive sock/pantyhose dressing device

Manufacturer:

EzyAs ABC stocking applicator company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tissue extraction bag

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fibreoptic light cable

Manufacturer:

Fiberoptics Technology Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin adhesive protective material

Manufacturer:

Lernapharm (Loris) Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou KoFa Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assistive scooter, electric-motor-driven

Manufacturer:

Quality Life Technologies Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible

Manufacturer:

Quality Life Technologies Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Incontinence penis clamp, reusable

Manufacturer:

Rennich Industries Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual goniometer

Manufacturer:

Meloq AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Continuous electronic patient thermometer, battery-powered

Manufacturer:

Cotronic Technology Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal aspirator, manual

Manufacturer:

Cotronic Technology Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal aspirator, manual

Manufacturer:

Cotronic Technology Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal aspirator, manual

Manufacturer:

Cotronic Technology Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal aspirator, manual

Manufacturer:

Cotronic Technology Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Incontinence penis clamp, reusable

Manufacturer:

Cross Innovations LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General specimen container IVD, no additive/medium

Manufacturer:

Kangmei Tianhong Biotech (Beijing) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Kangmei Tianhong Biotech (Beijing) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2/influenza A/B antigen IVD, kit, immunochromatographic test (ICT), rapid

Manufacturer:

Kangmei Tianhong Biotech (Beijing) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 125 (CA125) IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fibrinogen assay (factor I) IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple anaemia-related analyte IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple human hormone IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple urine analyte IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Plasma protein IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

Manufacturer:

MEDCAPTAIN Medical Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD, automated/semi-automated system

Manufacturer:

MEDCAPTAIN Medical Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, control

Manufacturer:

MEDCAPTAIN Medical Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, control

Manufacturer:

MEDCAPTAIN Medical Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin I IVD, kit, chemiluminescent immunoassay

Manufacturer:

MEDCAPTAIN Medical Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group B Streptococcus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Nanjing Liming Bio-Products Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human papillomavirus (HPV) antigen IVD, reagent

Manufacturer:

Nanjing Liming Bio-Products Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Nanjing Liming Bio-Products Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple vaginitis/vaginosis marker IVD, kit, colorimetric

Manufacturer:

Nanjing Liming Bio-Products Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type pathogen antigen/antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Nanjing Liming Bio-Products Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Nanjing Liming Bio-Products Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Nanjing Liming Bio-Products Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vibrio cholerae antigen (multiple serotype) IVD, kit, rapid ICT, clinical

Manufacturer:

Nanjing Liming Bio-Products Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical

Manufacturer:

Prometheus Bio Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical

Manufacturer:

Prometheus Bio Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Opiate/opiate metabolite IVD, kit, rapid ICT, clinical

Manufacturer:

Prometheus Bio Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Prometheus Bio Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Leishmania donovani immunoglobulin G (IgG)/IgM antibody IVD, reagent

Manufacturer:

Safecare Biotech (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen collection kit IVD, clinical

Manufacturer:

Shandong ThinkLab Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methylenetetrahydrofolate reductase (MTHFR) deficiency IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Shenzhen Huizhong Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Spinal muscular atrophy (SMA) IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Shenzhen Huizhong Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oxytocin IVD, control

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroglobulin IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid stimulating hormone receptor (TSHR) antibody IVD, control

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

1,25-Dihydroxy vitamin D3 IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Tailored Medical Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Homocysteine IVD, kit, enzyme spectrophotometry

Manufacturer:

Shenzhen Tailored Medical Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multichannel clinical chemistry analyser IVD, laboratory

Manufacturer:

Shenzhen Tailored Medical Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adenovirus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, rapid ICT, clinical

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, kit, rapid ICT, clinical

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza B virus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, kit, rapid ICT, clinical

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple gastrointestinal virus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, kit, rapid ICT, clinical

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Serum amyloid A IVD, reagent

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Blood cell lysis reagent IVD

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dental/surgical polymerization lamp

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Glucose monitoring system IVD, home-use

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Instrument/analyser cleaning agent IVD

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ultrasonic dental scaling/debridement system

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wearable percutaneous catheter/tube holder

Manufacturer:

I.V. House, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/medical face mask, single-use

Manufacturer:

Changde Gelan Medical Device Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urinary incontinence penis sheath/port, single-use

Manufacturer:

Changzhou DSB Medical Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

ENT chair, electric

Manufacturer:

66 Vision Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic examination slit lamp

Manufacturer:

66 Vision Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Retinoscope, battery-powered

Manufacturer:

66 Vision Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair electric-motor-driven propulsion system

Manufacturer:

ACEKARE

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Assay container IVD, single-use

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inoculating tool IVD, manual

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mechanical micropipette IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide coverslip IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pipette tip IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cotton wool roll

Manufacturer:

Jianerkang Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-body orifice lubricant

Manufacturer:

Jianerkang Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-woven gauze pad

Manufacturer:

Jianerkang Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/medical face mask, single-use

Manufacturer:

Jianerkang Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Woven gauze pad

Manufacturer:

Jianerkang Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone access channel kit

Manufacturer:

Jiangsu Changmei Medtech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Catheter/overtube balloon inflator, single-use

Manufacturer:

Jiangsu Changmei Medtech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pre-prescription spectacle lens

Manufacturer:

Jiangsu Maat Optical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pulse oximeter

Manufacturer:

Shenzhen Acurio Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Video capsule endoscopy system application software

Manufacturer:

ANKON Technologies Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound/centesis drainage receptacle

Manufacturer:

Apex (Guangzhou) Tools & Orthopedics Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Penile foreskin stretching kit

Manufacturer:

Platigo Solutions Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Penile foreskin stretching kit

Manufacturer:

Platigo Solutions Pty Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

ENFit oral/enteral syringe, single-use

Manufacturer:

Precispharma Containers Private Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment drape, single-use

Manufacturer:

Premier Guard Zhongshan Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical tissue/fluid collection bag

Manufacturer:

Premier Guard Zhongshan Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical tissue/fluid collection bag

Manufacturer:

Premier Guard Zhongshan Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical tissue/fluid collection bag

Manufacturer:

Premier Guard Zhongshan Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement preparation/delivery kit

Manufacturer:

Beijing Wanjie Medical Device Corporation Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/medical face mask, single-use

Manufacturer:

Fujian Kang Chen Daily Necessities Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Human genomic analysis interpretive software IVD

Manufacturer:

Beijing USCI Medical Devices Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inspiratory line humidification chamber, reusable

Manufacturer:

Wuxi Jike Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ankle/foot orthosis

Manufacturer:

Zhejiang Rehan Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Arm immobilizer

Manufacturer:

Zhejiang Rehan Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Elbow orthosis

Manufacturer:

Zhejiang Rehan Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee support orthosis

Manufacturer:

Zhejiang Rehan Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Toe separator

Manufacturer:

Zhejiang Rehan Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wrist orthosis

Manufacturer:

Zhejiang Rehan Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/medical face mask, single-use

Manufacturer:

Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic walking frame, foldable

Manufacturer:

Zhongshan First Medical Equipment Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bath back rest/seat

Manufacturer:

Zhongshan First Medical Equipment Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Enteral feeding noninvasive-component set

Manufacturer:

Beijing L&Z Medical Technology Development Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasogastric/orogastric tube

Manufacturer:

Beijing L&Z Medical Technology Development Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Walking stick/seat

Manufacturer:

Zhongshan First Medical Equipment Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic tonometer, manual

Manufacturer:

ZIEN Medical Technologies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic archwire/bracket ligature

Manufacturer:

Astar Orthodontics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic lock

Manufacturer:

Astar Orthodontics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic metal band

Manufacturer:

Astar Orthodontics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic tube

Manufacturer:

Astar Orthodontics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic wire

Manufacturer:

Astar Orthodontics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical handpiece, reusable

Manufacturer:

Baisheng Medical Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical handpiece, single-use

Manufacturer:

Baisheng Medical Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Manufacturer:

Baisheng Medical Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin stapler/staple, non-bioabsorbable

Manufacturer:

Baisheng Medical Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Home BPAP unit

Manufacturer:

BMC Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Home CPAP unit

Manufacturer:

BMC Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Inspiratory line humidification chamber, single-use

Manufacturer:

BMC Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polysomnograph

Manufacturer:

BMC Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Professional BPAP/high-flow respiratory unit

Manufacturer:

BMC Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Professional high-flow respiratory unit, humidifying

Manufacturer:

BMC Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ventilator breathing circuit, reusable

Manufacturer:

BMC Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, single-use

Manufacturer:

Chongqing Xishan Science & Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rotary/reciprocating endodontic file/rasp, single-use

Manufacturer:

DongGuan LinSky Medical Device Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rotary/reciprocating endodontic file/rasp, single-use

Manufacturer:

Easy Equipamentos Odontologicos LTDA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acupuncture electrical stimulation system

Manufacturer:

Pierenkemper GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Acupuncture point detector

Manufacturer:

Pierenkemper GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Physical therapy transcutaneous neuromuscular electrical stimulation system

Manufacturer:

Pierenkemper GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Kyphoplasty balloon catheter

Manufacturer:

Princetion Medical Scientific Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile/portable oxygen concentrator

Manufacturer:

Qingdao Kingon Medical Science and Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rectal/vaginal ultrasound imaging transducer

Manufacturer:

Shenzhen Sonosray Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Home BPAP unit

Manufacturer:

Shenzhen SunnyGrand Healthcare Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Professional high-flow respiratory unit, humidifying

Manufacturer:

Shenzhen SunnyGrand Healthcare Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic paper point

Manufacturer:

Shenzhen Superline Technology Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic bracket, metal

Manufacturer:

Shenzhen Superline Technology Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Manufacturer:

Shenzhen BSX Technology Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multiple vital physiological parameter monitoring system, clinical

Manufacturer:

Shenzhen Delica Medical Equipment Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Noninvasive vascular ultrasound system, line-powered

Manufacturer:

Shenzhen Delica Medical Equipment Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Physical therapy transcutaneous neuromuscular electrical stimulation system

Manufacturer:

Shenzhen Kentro Medical Electronics Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Physical therapy transcutaneous neuromuscular electrical stimulation system

Manufacturer:

Shenzhen Kentro Medical Electronics Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic wire

Manufacturer:

Shenzhen Superline Technology Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, ear

Manufacturer:

Shenzhen Pacom Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intermittent electronic patient thermometer

Manufacturer:

Shenzhen Pacom Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Physical therapy transcutaneous neuromuscular electrical stimulation system

Manufacturer:

Shenzhen Roundwhale Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, skin

Manufacturer:

Shenzhen Ruiankang Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Manufacturer:

Shenzhen Viatom Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual-inflation electronic sphygmomanometer, portable

Manufacturer:

Shenzhen Viatom Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose ultrasound imaging system

Manufacturer:

Shenzhen Wisonic Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Home BPAP unit

Manufacturer:

Shenzhen SunnyGrand Healthcare Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Arthroscopic shaver system blade, reusable

Manufacturer:

SIMAI Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic electrosurgical mucosal biopsy/resection set

Manufacturer:

SIMAI Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible video ureteroscope, single-use

Manufacturer:

SIMAI Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Leukocyte separation kit

Manufacturer:

Asahi Kasei Transfusion Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatological carbon dioxide laser system

Manufacturer:

Beijing Sincoheren Science and Technology Development Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbon dioxide monitor

Manufacturer:

Beijing Wanliandaxinke Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External counterpulsation system, mobile

Manufacturer:

Chongqing PSK-Health Sci-Tech Development Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cryosurgical system temperature probe

Manufacturer:

Hygea Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General cryosurgical system, cryogen gas, electronic

Manufacturer:

Hygea Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Invasive-pressure external transducer, single-use

Manufacturer:

Jingzhou Yihai Technology Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

Manufacturer:

Jiangsu Hope Biomedical Science & Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrolytic-plasma electrosurgical system

Manufacturer:

Jiangsu Breath Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Memory-alloy orthopaedic fixation plate

Manufacturer:

Lanzhou Seemine SMA Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial

Manufacturer:

LifeScience PLUS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stationary basic diagnostic x-ray system, digital

Manufacturer:

ORICH Medical Equipment (Tianjin) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/surgical polymerization lamp

Manufacturer:

Nanning Baolai Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose medical fibre padding

Manufacturer:

Naturs Design, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Analgesic transcutaneous electrical nerve stimulation system

Manufacturer:

Netop Industrial Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Microbiological transport medium IVD

Manufacturer:

Merah Medical Sdn Bhd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Patient transfer system, manual

Manufacturer:

Taitung Instruments Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye heat therapy pack, reusable

Manufacturer:

The Hilsinger Company Parent, LLC dba Bruder Healthcare

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hot/cold therapy pack, reusable

Manufacturer:

The Hilsinger Company Parent, LLC dba Bruder Healthcare

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vision testing/training chart

Manufacturer:

The Mars Perceptrix Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Video intubation laryngoscope blade

Manufacturer:

THREE LIONS LIMITED

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Adhesive bandage

Manufacturer:

Tronjen Medical Technology Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Adhesive bandage

Manufacturer:

Tronjen Medical Technology Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Glove liner

Manufacturer:

UShare Medical Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid intubation laryngoscope, single-use

Manufacturer:

UShare Medical Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood cell lysis reagent IVD

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Blood glucose/blood pressure monitoring system, home-use

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haemoglobin analyser IVD, laboratory, semi-automated

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haemoglobin detection IVD, reagent

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyser IVD, laboratory, semi-automated

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Reticulocyte count IVD, kit, cell count

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dental casting non-noble alloy

Manufacturer:

Vedia Solutions, Division of Laxmi Dental Export Pvt Ltd.,

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental occlusal splint, preformed, single-use

Manufacturer:

Vedia Solutions, Division of Laxmi Dental Export Pvt Ltd.,

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant system

Manufacturer:

Biomate Medical Devices Technology Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixture/appliance dental drill bit, reusable

Manufacturer:

Biomate Medical Devices Technology Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Freestanding patient positioner, reusable

Manufacturer:

Walgreen Health Solutions, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spectacle frame

Manufacturer:

Wenzhou Rainbow Optical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Capillary blood collection tube IVD, no additive

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cell culture line IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Centrifuge tube IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clerical marking pen

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose absorbent tip applicator/swab, single-use

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Histological tissue cassette biopsy insert IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Histology tissue cassette IVD, laboratory processing, single-use

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Histology tissue cassette IVD, laboratory processing, single-use

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Instrument/analyser specimen/reagent container carrier IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microplate IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide coverslip IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide tray

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-evacuated erythrocyte sedimentation rate (ESR) tube IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oral specimen collection swab

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Specimen transfer scooping tool IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tissue freezing/embedding medium IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anaesthesia face mask, reusable

Manufacturer:

Omnimate Enterprise Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Breathing circuit bag, single-use

Manufacturer:

Omnimate Enterprise Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixed examination/treatment room light

Manufacturer:

Burton Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/medical face mask, single-use

Manufacturer:

BYD Precision Manufacture Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile/portable oxygen concentrator

Manufacturer:

Oxytek Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair, electric-motor-driven, occupant-controlled, manual-steering, non-collapsible

Manufacturer:

PARAVAN GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Operating table torso positioner

Manufacturer:

Opitek International

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cervicothoracic spine orthosis

Manufacturer:

OPTEC USA Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hip orthosis

Manufacturer:

OPTEC USA Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Penile vacuum device

Manufacturer:

BonRoux Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient health record information system application software

Manufacturer:

HERCARE Sweden AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Transcutaneous electrical stimulation electrode, reusable

Manufacturer:

GMDASZ Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraoral optical scanning system

Manufacturer:

Guangdong Launca Medical Device Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraoral optical scanning system

Manufacturer:

Guangdong Launca Medical Device Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical gown, single-use

Manufacturer:

Haian Medigauze Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Air-conduction hearing aid, behind-the-ear

Manufacturer:

Foshan Vohom Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medicine bottle

Manufacturer:

Ningbo High-Tech Bluesky Manufactory & Trading Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral vascular guidewire, manual

Manufacturer:

Global-Thaixon Precision Industry Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heated respiratory humidifier

Manufacturer:

Great Group Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ventilator breathing circuit, single-use

Manufacturer:

Great Group Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Soft corrective contact lens, daily-wear

Manufacturer:

HaiChang Contact Lens Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nylon suture, non-bioabsorbable, monofilament

Manufacturer:

HuaiYin Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nylon suture, non-bioabsorbable, multifilament

Manufacturer:

HuaiYin Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

Manufacturer:

HuaiYin Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyester suture, bioabsorbable, multifilament, non-antimicrobial

Manufacturer:

HuaiYin Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyolefin/fluoropolymer suture, monofilament

Manufacturer:

HuaiYin Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bedside infusion pump, single-channel

Manufacturer:

Hunan Beyond Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bedside syringe pump

Manufacturer:

Hunan Beyond Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Home BPAP unit

Manufacturer:

Hunan Beyond Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Home CPAP unit

Manufacturer:

Hunan Beyond Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Irrigation negative-pressure wound therapy dressing

Manufacturer:

International Medical Research Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Respiratory oxygen sensor

Manufacturer:

IT Dr. Gambert GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy tube, non-reinforced, non-customized, single-use

Manufacturer:

Jiangsu IAWA Bioscience Engineering Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose multi-parameter bedside monitor

Manufacturer:

Medical ECONET GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multidisciplinary medical image management software

Manufacturer:

MediMatic Srl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscope antifog solution

Manufacturer:

MoNo chem-pharm Produkte GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal phototherapy system

Manufacturer:

Netop Industrial Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay

Manufacturer:

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, kit, rapid ICT, clinical

Manufacturer:

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Carcinoembryonic antigen (CEA) IVD, kit, rapid ICT, clinical

Manufacturer:

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing

Manufacturer:

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1 antibody IVD, kit, rapid ICT, clinical

Manufacturer:

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunoassay reagent vehicle reader IVD

Manufacturer:

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microalbumin IVD, kit, rapid ICT, clinical

Manufacturer:

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, kit, rapid ICT, clinical

Manufacturer:

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, kit, rapid ICT, clinical

Manufacturer:

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay, rapid

Manufacturer:

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Orthodontic progressive aligner

Manufacturer:

Ningbo Sezen Technology Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Complete lower denture

Manufacturer:

Shenzhen New Perfect Exact Dental Research Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Complete upper denture

Manufacturer:

Shenzhen New Perfect Exact Dental Research Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Custom-made dental crown, metal/ceramic

Manufacturer:

Shenzhen New Perfect Exact Dental Research Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Custom-made dental crown, polymer

Manufacturer:

Shenzhen New Perfect Exact Dental Research Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental bridge, metal-polymer

Manufacturer:

Shenzhen New Perfect Exact Dental Research Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental bridge, polymer

Manufacturer:

Shenzhen New Perfect Exact Dental Research Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, kit, rapid ICT, self-testing

Manufacturer:

Core Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing

Manufacturer:

Core Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Core Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Manufacturer:

Core Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

Manufacturer:

Core Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose analyser IVD, home-use

Manufacturer:

AEON DIAGNOSTIC Technology Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose monitoring system IVD, home-use

Manufacturer:

AEON DIAGNOSTIC Technology Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, kit, rapid ICT, self-testing

Manufacturer:

Abiores Technology (Beijing) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Abiores Technology (Beijing) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Abiores Technology (Beijing) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Biotech India Limited (a subsidiary of Kilpest India Limited)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Leukaemia-associated fusion gene IVD, control

Manufacturer:

3B BlackBio Biotech India Limited (a subsidiary of Kilpest India Limited)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Leukaemia-associated fusion gene IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Biotech India Limited (a subsidiary of Kilpest India Limited)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microbiological transport medium IVD

Manufacturer:

3B BlackBio Biotech India Limited (a subsidiary of Kilpest India Limited)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Biotech India Limited (a subsidiary of Kilpest India Limited)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Biotech India Limited (a subsidiary of Kilpest India Limited)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Acute promyelocytic leukaemia (APL) genetic mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chikungunya virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor II (prothrombin) mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ebola virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

KRAS gene mutation IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Leukaemia-associated fusion gene IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methylated DNA IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methylenetetrahydrofolate reductase (MTHFR) deficiency IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

MRSA nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Chlamydia species nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple human parainfluenza virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type tropical pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Philadelphia chromosome/BCR-ABL transcript IVD, control

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thiopurine S-methyltransferase (TPMT) gene polymorphism IVD, kit, nucleic acid technique (NAT)

Manufacturer:

3B BlackBio Dx Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD10 cell marker IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD19 cell marker IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD23 cell marker IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD25 cell marker IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD3 cell marker IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD34 cell marker IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD41 cell marker IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD45RO cell marker IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD56 neural cell adhesion molecule-1 (NCAM-1) IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

CD79a cell marker IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Flow cytometry analyser IVD, semi-automated

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HLA-B27 tissue typing IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HLA-DR antigen tissue typing IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interleukin-1 alpha (IL-1a) IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple CD cell marker IVD, antibody

Manufacturer:

Agilent Biosciences (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Beijing Kinghawk Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hevea-latex surgical glove, non-powdered, non-antimicrobial

Manufacturer:

Careglove Global SDN BHD

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental anaesthesia syringe/needle

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental articulation paper

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Isolation gown, single-use

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Root canal irrigation blunt needle

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Root canal irrigation blunt needle

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anaesthesia Luer syringe

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental amalgam carrier

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental material mixing nozzle

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental suction system

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental throat shield

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dry medical towel/wipe, single-use

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Root canal irrigation blunt needle

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sterilization container liner

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/medical face mask, non-antimicrobial, single-use

Manufacturer:

CDM Center of Excellence Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Manufacturer:

Shanghai Sanyou Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Troponin T IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay container IVD, single-use

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Centrifuge tube IVD

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cervical cytology brush

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cervical cytology scraper, single-use

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose absorbent tip applicator/swab, single-use

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mechanical micropipette IVD

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microbial cryotube IVD

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Microscope slide coverslip IVD

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide holder, preparation/staining

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Microscope slide tray

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Microtome blade IVD, single-use

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Test tube rack

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Test tube/reservoir cap

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vaginal speculum, single-use

Manufacturer:

DiaTrust Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Disposable battery pack

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Disposable battery pack

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic manual linear cutting stapler, single-use

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic motorized cutting stapler, single-use

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic motorized cutting stapler, single-use

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic surgical ligation clip applier, reusable

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemorrhoidal surgical stapler, single-use

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraluminal circular stapler, single-use

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery manual linear cutting stapler, single-use

Manufacturer:

Fengh Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Balance ball exerciser

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Body/limb elastic exerciser

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam frame

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam punch

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam, Hevea-latex

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vocational/recreational cushion

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam clamp

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam frame

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vocational/recreational cushion

Manufacturer:

Sanctuary Health Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic intravenous administration set, invasive

Manufacturer:

Shenzhen Boon Medical Supply Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vaginal speculum, single-use

Manufacturer:

Shenzhen Boon Medical Supply Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular port administration set

Manufacturer:

Shenzhen Boon Medical Supply Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose patient temperature probe, reusable

Manufacturer:

Shenzhen Changke Connect Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic lead set, reusable

Manufacturer:

Shenzhen Changke Connect Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose patient temperature probe, single-use

Manufacturer:

Shenzhen Changke Connect Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pulse oximetry telemetric monitoring system

Manufacturer:

Shenzhen Changke Connect Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tracheostomy tube speech valve

Manufacturer:

Shenzhen Prunus Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrode conductive skin pad, reusable

Manufacturer:

Dongguan Quanding Medical Supplies Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External defibrillation electrode, adult, single-use

Manufacturer:

Dongguan Quanding Medical Supplies Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment/instrument drape, reusable

Manufacturer:

Dongguan Senmed Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Manufacturer:

Rubbercare Protection Products Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood glucose/blood pressure monitoring system, point-of-care

Manufacturer:

e-LinkCare Meditech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Diagnostic spirometer, professional

Manufacturer:

e-LinkCare Meditech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General specimen container IVD, additive/medium

Manufacturer:

e-LinkCare Meditech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Manufacturer:

e-LinkCare Meditech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Uric acid IVD, reagent

Manufacturer:

e-LinkCare Meditech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Finger/hand exerciser

Manufacturer:

ELASTOMADE ACCESSORIES SDN. BHD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External limb prosthesis socket liner

Manufacturer:

Embreis AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-adhesive device retention bandage

Manufacturer:

RAFFIN MEDICAL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Continuous electronic patient thermometer, battery-powered

Manufacturer:

Cotronic Technology Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flatus tube, single-use

Manufacturer:

Cotronic Technology Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal irrigation applicator

Manufacturer:

Cotronic Technology Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible video cystoscope, single-use

Manufacturer:

MacroLux Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible video bronchoscope, single-use

Manufacturer:

MacroLux Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible video ureteroscope, single-use

Manufacturer:

MacroLux Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid video hysteroscope

Manufacturer:

MacroLux Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Clavicle orthosis

Manufacturer:

Zhejiang Rehan Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Compression/pressure sock/stocking, reusable

Manufacturer:

Zhejiang Rehan Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand/finger splint, reusable

Manufacturer:

Zhejiang Rehan Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hip orthosis

Manufacturer:

Zhejiang Rehan Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lumbar spine orthosis

Manufacturer:

Zhejiang Rehan Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthotic insole, prefabricated, non-antimicrobial

Manufacturer:

Zhejiang Rehan Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scrotal support

Manufacturer:

Zhejiang Rehan Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thoracic spine orthosis

Manufacturer:

Zhejiang Rehan Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic bracket, ceramic

Manufacturer:

Astar Orthodontics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic retainer

Manufacturer:

Astar Orthodontics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical return electrode, reusable

Manufacturer:

Baisheng Medical Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical return electrode, single-use

Manufacturer:

Baisheng Medical Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

Manufacturer:

Baisheng Medical Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Enteral feeding pump

Manufacturer:

Beijing L&Z Medical Technology Development Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

CPAP/BPAP face mask, reusable

Manufacturer:

BMC Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Home BPAP unit

Manufacturer:

BMC Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Home CPAP unit

Manufacturer:

BMC Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal oxygen cannula, basic

Manufacturer:

BMC Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polysomnograph

Manufacturer:

BMC Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Professional high-flow respiratory unit, humidifying

Manufacturer:

BMC Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ventilator breathing circuit, reusable

Manufacturer:

BMC Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ventilator breathing circuit, single-use

Manufacturer:

BMC Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ventilator breathing circuit, single-use

Manufacturer:

BMC Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemodialysis blood tubing set, single-use

Manufacturer:

Chengdu Xinjin Shifeng Medical Appratures & Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bur, single-use

Manufacturer:

Chongqing Xishan Science & Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical saw blade, sagittal, single-use

Manufacturer:

Chongqing Xishan Science & Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasonic nebulizing system

Manufacturer:

Dongguan SIMZO Electronic Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blue/red/infrared phototherapy lamp

Manufacturer:

Foshan Gaunying Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Balloon kyphoplasty kit

Manufacturer:

Princetion Medical Scientific Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urethral dilatation catheter, non-medicated

Manufacturer:

Princetion Medical Scientific Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urethral dilator, single-use

Manufacturer:

Princetion Medical Scientific Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose syringe, single-use

Manufacturer:

PT. Oneject Indonesia

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, ear/skin

Manufacturer:

Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Angiography kit

Manufacturer:

Shenzhen Boon Medical Supply Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anaesthesia depth monitor

Manufacturer:

Shenzhen Delica Medical Equipment Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cerebral oximeter

Manufacturer:

Shenzhen Delica Medical Equipment Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electroencephalograph

Manufacturer:

Shenzhen Delica Medical Equipment Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, skin

Manufacturer:

Shenzhen Finicare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, skin

Manufacturer:

Shenzhen Pacom Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Analgesic transcutaneous electrical nerve stimulation system

Manufacturer:

Shenzhen Roundwhale Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rotary/reciprocating endodontic file/rasp, reusable

Manufacturer:

Shenzhen Rogin Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Extracorporeal ultrasound imaging transducer, hand-held

Manufacturer:

Shenzhen Sonosray Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, ear/skin

Manufacturer:

Shenzhen Urion Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nebulizing system delivery set, reusable

Manufacturer:

Shenzhen Urion Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rotary/reciprocating endodontic file/rasp, single-use

Manufacturer:

Shenzhen Superline Technology Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Manufacturer:

Shenzhen Viatom Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual-inflation electronic sphygmomanometer, portable

Manufacturer:

Shenzhen Viatom Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose ultrasound imaging system

Manufacturer:

ShenZhen Well.d Medical Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose multi-parameter bedside monitor

Manufacturer:

Shenzhen Wisonic Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose ultrasound imaging system

Manufacturer:

Shenzhen Wisonic Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Professional high-flow respiratory unit, humidifying, manual

Manufacturer:

Shenzhen SunnyGrand Healthcare Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatological diode laser system

Manufacturer:

Beijing Sincoheren Science and Technology Development Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatological frequency-doubled solid-state laser system

Manufacturer:

Beijing Sincoheren Science and Technology Development Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbon dioxide sensor/cable

Manufacturer:

Beijing Wanliandaxinke Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose multi-parameter bedside monitor

Manufacturer:

Better Life Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Buffered wash solution IVD, automated/semi-automated system

Manufacturer:

MEDCAPTAIN Medical Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, reagent

Manufacturer:

MEDCAPTAIN Medical Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent substrate reagent IVD

Manufacturer:

MEDCAPTAIN Medical Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interleukin-6 (IL-6) IVD, kit, chemiluminescent immunoassay

Manufacturer:

MEDCAPTAIN Medical Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyser IVD, laboratory

Manufacturer:

MEDCAPTAIN Medical Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay

Manufacturer:

MEDCAPTAIN Medical Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Manufacturer:

MEDCAPTAIN Medical Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Nanjing Liming Bio-Products Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Nanjing Liming Bio-Products Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple respiratory virus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Nanjing Liming Bio-Products Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Salmonella species antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Nanjing Liming Bio-Products Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neisseria gonorrhoeae antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Nanjing Liming Bio-Products Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Nanjing Liming Bio-Products Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, kit, rapid ICT, clinical

Manufacturer:

Nanjing Liming Bio-Products Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Nanjing Liming Bio-Products Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Nanjing Liming Bio-Products Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Manufacturer:

Prometheus Bio Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 neutralizing antibody IVD, kit, chemiluminescent immunoassay

Manufacturer:

Prometheus Bio Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Brucella abortus total antibody IVD, reagent

Manufacturer:

Safecare Biotech (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, kit, rapid ICT, clinical

Manufacturer:

Safecare Biotech (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

Manufacturer:

Safecare Biotech (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, rapid ICT, clinical

Manufacturer:

Safecare Biotech (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis A virus immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Safecare Biotech (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG)/IgM antibody IVD, reagent

Manufacturer:

Safecare Biotech (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Safecare Biotech (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Trypanosoma cruzi total antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Safecare Biotech (Hangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Shenzhen Huizhong Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid sample preparation instrument IVD

Manufacturer:

Shenzhen MDERN Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid stimulating hormone (TSH) IVD, control

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin I IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vitamin B12 IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Channel Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Folate (vitamin B9) IVD, kit, radioimmunoassay

Manufacturer:

Shenzhen Tailored Medical Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methylenetetrahydrofolate reductase (MTHFR) deficiency IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Shenzhen Tailored Medical Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vitamin B12 IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Tailored Medical Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fatty acid binding protein (FABP) IVD, reagent

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza A virus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rotavirus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Shenzhen JetMay Care Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Centrifuge tube IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Histological tissue cassette biopsy insert IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Histology tissue cassette IVD, laboratory processing, single-use

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory waste receptacle IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microbial cryotube IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microplate IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Non-evacuated erythrocyte sedimentation rate (ESR) tube IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antiseptic swab

Manufacturer:

Jianerkang Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin-cleaning wipe, non-sterile

Manufacturer:

Jianerkang Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pre-prescription spectacle lens

Manufacturer:

Jiangsu East Optics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscopic gastrointestinal stenosis dilator

Manufacturer:

Jiangsu Changmei Medtech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/medical face mask, single-use

Manufacturer:

Jiangsu IAWA Bioscience Engineering Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical irrigation system nozzle

Manufacturer:

Apex (Guangzhou) Tools & Orthopedics Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Disposable surgical irrigation/aspiration system

Manufacturer:

Apex (Guangzhou) Tools & Orthopedics Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wire/ligature passer, reusable

Manufacturer:

Apex (Guangzhou) Tools & Orthopedics Co.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multiple vital physiological parameter monitoring system, clinical

Manufacturer:

APK Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ankle/foot orthosis

Manufacturer:

POD Active Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Faecal incontinence collector, skin-fixation

Manufacturer:

Changzhou DSB Medical Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Reticulocyte count IVD, kit, cell count

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine analyser IVD, laboratory

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Surgical/medical face mask, single-use

Manufacturer:

Hunan Triplex Precision Medical Devices Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Arm procedure positioner, single-use

Manufacturer:

I.V. House, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand/finger splint, single-use

Manufacturer:

I.V. House, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

First aid absorbent pad/bandage

Manufacturer:

AKLA AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cancer-related multiple gene mutation profile kit IVD

Manufacturer:

Beijing USCI Medical Devices Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Dynamiker Biotechnology (Tianjin) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Monkeypox virus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Dynamiker Biotechnology (Tianjin) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Aspergillus species antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Dynamiker Biotechnology (Tianjin) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 neutralizing antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Post-PCR cleanup kit IVD

Manufacturer:

Guangzhou Deaou Bio-technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Kangmei Tianhong Biotech (Beijing) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Kangmei Tianhong Biotech (Beijing) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adrenocorticotropic hormone (ACTH) IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 15-3 (CA15-3) IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 19-9 (CA19-9) IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ferritin IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Heparin anti-Xa IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple apolipoprotein IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple thyroid marker IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Osmolality IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, control

Manufacturer:

LGC Clinical Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Medical equipment drape, single-use

Manufacturer:

Premier Guard Zhongshan Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/medical face mask, single-use

Manufacturer:

Premier Guard Zhongshan Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment drape, single-use

Manufacturer:

Premier Guard Zhongshan Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Retinoscope, battery-powered

Manufacturer:

66 Vision Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Direct ophthalmoscope

Manufacturer:

66 Vision Tech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Breast pump, electric

Manufacturer:

Acute Ideas Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intermittent electronic patient thermometer

Manufacturer:

Acute Ideas Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal aspirator, manual

Manufacturer:

Acute Ideas Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiograph, professional, multichannel

Manufacturer:

Medical ECONET GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin-cleaning wipe, non-sterile

Manufacturer:

Lights Medical Manufacture Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diagnostic x-ray system generator, portable

Manufacturer:

Medical ECONET GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, kit, rapid ICT, self-testing

Manufacturer:

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus total antibody IVD, kit, rapid ICT, clinical

Manufacturer:

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical

Manufacturer:

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Manufacturer:

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total human chorionic gonadotropin IVD, reagent

Manufacturer:

NewScen Coast Bio-Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ankle/foot orthosis

Manufacturer:

Betterguards Technology GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Corneal trephine, single-use

Manufacturer:

Surgistar Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual scalpel blade, single-use

Manufacturer:

Surgistar Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Phacoemulsification system handpiece

Manufacturer:

Surgistar Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vitreous body prosthesis

Manufacturer:

Guangzhou Vesber Biotechnology Co Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemoperfusion system absorption column

Manufacturer:

Jafron Biomedical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrolytic-plasma endoscopic electrosurgical electrode

Manufacturer:

Jiangsu Breath Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-rechargeable public semi-automated external defibrillator

Manufacturer:

Jousing Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone-screw internal spinal fixation system, non-sterile

Manufacturer:

Shanghai Sanyou Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone screw, non-bioabsorbable, non-sterile

Manufacturer:

Shanghai Sanyou Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymeric spinal interbody fusion cage

Manufacturer:

Shanghai Sanyou Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Spinal fixation plate, non-bioabsorbable

Manufacturer:

Shanghai Sanyou Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood smearing manual instrument IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cervical cytology brush

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cryobiological storage container

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General specimen microscopy slide IVD, single-use

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen receptacle transport container

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Histological tissue cassette biopsy insert IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inoculating tool IVD, manual

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mechanical micropipette IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide box

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Microscope slide cabinet

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Microscope slide folder

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-evacuated erythrocyte sedimentation rate (ESR) tube IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pipette tip IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pipette tip IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Specimen transfer scooping tool IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Test tube/reservoir cap IVD

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tissue embedding mould IVD, reusable

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tissue embedding mould IVD, single-use

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tongue depressor, examination, single-use

Manufacturer:

Citotest Labware Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-woven gauze pad

Manufacturer:

Tronjen Medical Technology Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical suction system collection container, single-use

Manufacturer:

UShare Medical Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/surgical polymerization lamp

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Full blood count IVD, calibrator

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose analyser IVD, home-use

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haematological cell analyser IVD

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Instrument/analyser cleaning agent IVD

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lactate IVD, control

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple urine analyte IVD, control

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ultrasonic dental scaling/debridement system

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urine analyser IVD, laboratory

Manufacturer:

URIT Medical Electronic Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dental casting non-noble alloy

Manufacturer:

Vedia solutions, Div of Laxmidental Export Pvt Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental occlusal splint, preformed, single-use

Manufacturer:

Vedia solutions, Div of Laxmidental Export Pvt Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic progressive aligner

Manufacturer:

Vedia solutions, Div of Laxmidental Export Pvt Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Temporary dental crown/bridge resin

Manufacturer:

Vedia solutions, Div of Laxmidental Export Pvt Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic progressive aligner

Manufacturer:

Vedia Solutions, Division of Laxmi Dental Export Pvt Ltd.,

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Temporary dental crown/bridge resin

Manufacturer:

Vedia Solutions, Division of Laxmi Dental Export Pvt Ltd.,

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Biomate Medical Devices Technology Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant system

Manufacturer:

Biomate Medical Devices Technology Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant system

Manufacturer:

Biomate Medical Devices Technology Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Elbow/ankle friction/impact protector

Manufacturer:

Walgreen Health Solutions, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient transfer/turning sheet

Manufacturer:

Walgreen Health Solutions, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heated respiratory humidifier

Manufacturer:

Wuxi Jike Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-ISO80369-standardized small-bore linear connector, reusable

Manufacturer:

Wuxi Jike Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-ISO80369-standardized small-bore linear connector, reusable

Manufacturer:

Wuxi Jike Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraoral optical scanning system

Manufacturer:

Shenzhen Xpectvision Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound-nonadherent dressing, absorbent, non-antimicrobial

Manufacturer:

Solaplus Biotech Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/medical face mask, single-use

Manufacturer:

Fujian Kang Chen Daily Necessities Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External ocular measurement camera

Manufacturer:

Suzhou Microclear Medical Instruments Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose ultrasound imaging system

Manufacturer:

Sonostar Technologies Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Nucleic acid sample preparation instrument IVD

Manufacturer:

Zinexts Life Science Corp.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Nucleic acid sample preparation instrument IVD

Manufacturer:

Zinexts Life Science Corp.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Zinexts Life Science Corp.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Zinexts Life Science Corp.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 22, 2024

Hand-held ultrasound imaging system, body-surface

Manufacturer:

Sonostar Technologies Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Pipette tip IVD

Manufacturer:

Zhejiang Biorear Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Assay container IVD, single-use

Manufacturer:

Zhejiang Biorear Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Infrared patient thermometer, skin

Manufacturer:

Shenzhen Ruiankang Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 10, 2024

Urine-sampling urethral catheter

Manufacturer:

Demersan Biyoteknoloji İmalat San.ve Tic.A.Ş

Type:

General Medical Device

Registration Date:

Nov 10, 2024

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Manufacturer:

Shenzhen Ruiankang Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 10, 2024

Surgical irrigation system nozzle

Manufacturer:

Apex (Suzhou) Medical Products Company

Type:

General Medical Device

Registration Date:

Nov 4, 2024

Disposable surgical irrigation/aspiration system

Manufacturer:

Apex (Suzhou) Medical Products Company

Type:

General Medical Device

Registration Date:

Nov 4, 2024

Rotary/reciprocating endodontic file/rasp, single-use

Manufacturer:

Shenzhen Denco Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Oct 13, 2024

Medical ruler, reusable

Manufacturer:

Shenzhen Denco Medical Co., Ltd

Type:

General Medical Device

Registration Date:

Oct 13, 2024

Alternating-pressure bed mattress

Manufacturer:

Shenzhen Fitconn Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Oct 9, 2024

Benchtop nebulizer, non-heated

Manufacturer:

Shenzhen Fitconn Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Oct 9, 2024

Bedside infusion pump, single-channel

Manufacturer:

Shenzhen Hawk Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Oct 9, 2024

Enteral feeding pump

Manufacturer:

Shenzhen Hawk Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Oct 9, 2024

Bedside syringe pump

Manufacturer:

Shenzhen Hawk Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Oct 9, 2024

Pulse oximeter

Manufacturer:

Shenzhen Raysintone Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Sep 10, 2024

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Zhejiang Quark Biological Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 25, 2024

General specimen collection kit IVD, clinical

Manufacturer:

Zhejiang Quark Biological Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 25, 2024

Blood culture analyser IVD

Manufacturer:

Zhejiang Quark Biological Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 25, 2024

Anaerobic-microorganism antimicrobial susceptibility culture medium IVD

Manufacturer:

Zhejiang Quark Biological Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 25, 2024

SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Zhejiang Quark Biological Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 25, 2024

Basic/simple nutrient agar culture medium IVD

Manufacturer:

Zhejiang Quark Biological Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 25, 2024

Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible

Manufacturer:

Quality Life Technologies Co. Ltd

Type:

General Medical Device

Registration Date:

Jun 17, 2024

Assistive scooter, electric-motor-driven

Manufacturer:

Quality Life Technologies Co. Ltd

Type:

General Medical Device

Registration Date:

Jun 17, 2024

Calcitonin IVD, calibrator

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Cancer antigen 125 (CA125) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Cancer antigen 72-4 (CA72-4) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Carcinoembryonic antigen (CEA) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

D-dimer IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Dehydroepiandrosterone (DHEA) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Dehydroepiandrosterone sulfate (DHEAS) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Digoxin therapeutic drug monitoring IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Erythropoietin (EPO) IVD, calibrator

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Erythropoietin (EPO) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Erythropoietin (EPO) IVD, reagent

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Ferritin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Folate (vitamin B9) IVD, reagent

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Free testosterone IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Free testosterone IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Free triiodothyronine (FT3) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Glutamic acid decarboxylase antibody (anti-GAD) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Haptoglobin IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Herpes simplex virus 1 (HSV1) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Human growth hormone (HGH) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Influenza A virus immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Inhibin B IVD, calibrator

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Insulin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Interleukin-6 (IL-6) IVD, reagent

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Iron IVD, calibrator

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Iron IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Jo-1 antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Listeria monocytogenes immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Luteinizing hormone (LH) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Luteinizing hormone (LH) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Multiple form 25-hydroxy Vitamin D IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Myoglobin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Phospholipid antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Procalcitonin (PCT) IVD, calibrator

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Procalcitonin (PCT) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Prolactin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Renin IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Respiratory syncytial virus (RSV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

SARS-CoV-2 immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, calibrator

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

SARS-CoV-2 neutralizing antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Sex hormone binding globulin (SHBG) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Smith antibody (anti-Sm) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Soluble transferrin receptor IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Squamous cell carcinoma antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Thyroglobulin IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Thyroid uptake (T-uptake) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Thyrosin phosphatase antibody (anti-IA2) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Total testosterone IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Total testosterone IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Total thyroxine (TT4) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Treponema pallidum immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Troponin I IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

U1-RNP antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Yersinia enterocolitica immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Zinc transporter (ZnT) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Estradiol (oestradiol) (E2) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Estrone (oestrone) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Ferritin IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Free estriol (oestriol) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Gliadin antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Haematological cell analyser IVD

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Haptoglobin IVD, calibrator

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Hepcidin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Influenza B virus immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Influenza B virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Inhibin A IVD, calibrator

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Inhibin A IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Inhibin B IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Insulin antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Insulin IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Leptin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Multiple Brucella species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Multiple Campylobacter species antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Multiple enterovirus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Multiple thyroid antibody IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Mumps virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Neopterin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Neuron-specific enolase (NSE) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Progesterone IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Prolactin IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Renin IVD, calibrator

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Thyroid stimulating hormone (TSH) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Thyroxine binding globulin (TBG) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Total cortisol IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Total prostate specific antigen (tPSA) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Total triiodothyronine (TT3) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Vitamin B12 IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Wash/cleaning solution IVD, automated/semi-automated system

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Yersinia enterocolitica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Calcitonin IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Calprotectin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Cancer antigen 125 (CA125) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Cancer antigen 242 (CA242) IVD, reagent

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Candida albicans immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Chromogranin A IVD, calibrator

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Chromogranin A IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Coxsackie B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Coxsackie B virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Creatine kinase myocardial isoenzyme (CKMB) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Cytokeratin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Dehydroepiandrosterone (DHEA) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Digoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Enzyme immunoassay (EIA) analyser IVD

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Folate (vitamin B9) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Free (unbound) prostate specific antigen (fPSA) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Free thyroxine (FT4) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Haptoglobin IVD, antibody

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Helicobacter pylori total antibody IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Herpes simplex virus 2 (HSV2) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Insulin IVD, calibrator

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Histone antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Human epididymis protein 4 (HE4) IVD, reagent

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Human growth hormone (HGH) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Immunoglobulin removal reagent IVD

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Airway suction catheter

Manufacturer:

Suzhou Yudu Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Nasogastric/orogastric tube

Manufacturer:

Suzhou Yudu Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

General-purpose ultrasound imaging system

Manufacturer:

Teratech Corporation

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Spring-loaded pneumoperitoneum needle, single-use

Manufacturer:

Unimicro Medical Systems (Shenzhen) Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Electronic gravity infusion controller administration set

Manufacturer:

Vietnam Medical Plastic JSC

Type:

General Medical Device

Registration Date:

Apr 11, 2024

General-purpose syringe/needle

Manufacturer:

Vietnam Medical Plastic JSC

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Hypodermic needle, single-use

Manufacturer:

Vietnam Medical Plastic JSC

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Soft corrective contact lens, daily-disposable

Manufacturer:

Yung Sheng Optical Co. Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Surgical/medical face mask, single-use

Manufacturer:

Shenzhen Horb Technology Corp., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

17-Hydroxyprogesterone IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Adiponectin IVD, calibrator

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Adiponectin IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Adiponectin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Adrenocorticotropic hormone (ACTH) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Alpha-fetoprotein (AFP) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Aspergillus fumigatus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Blood cell lysis reagent IVD

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Cancer antigen 19-9 (CA19-9) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Bordetella pertussis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Borrelia garinii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Buffered sample diluent IVD, automated/semi-automated system

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

C-peptide IVD, calibrator

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

C-peptide IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

C-peptide IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

C-reactive protein (CRP) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Aldosterone IVD, calibrator

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Aldosterone IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Aldosterone IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Allergen-specific immunoglobulin E (IgE) antibody IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Alpha-fetoprotein (AFP) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Anti-Mullerian hormone (AMH) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Borrelia afzelii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Buffered wash solution IVD, automated/semi-automated system

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Cancer antigen 15-3 (CA15-3) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Candida albicans immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Carcinoembryonic antigen (CEA) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Centromere protein antibody (anti-CENP) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Chromogranin A IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Influenza A virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Inhibin A IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Inhibin B IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Leptin IVD, calibrator

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Leptin IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Measles virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Multiple Brucella species immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Multiple enterovirus immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Multiple enterovirus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Multiple human parainfluenza virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Mycoplasma pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Myoglobin IVD, calibrator

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Myoglobin IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Assistive scooter, electric-motor-driven

Manufacturer:

Pihsiang Machinery Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Parathyroid hormone (PTH) IVD, calibrator

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Procalcitonin (PCT) IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Progesterone IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Renin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Ribosomal phosphoprotein antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

SARS-CoV-2 immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Sex hormone binding globulin (SHBG) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Sperm antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Thyroglobulin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Tick-borne encephalitis (TBE) virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Tick-borne encephalitis (TBE) virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Total cortisol IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Toxocara canis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Trisomy 21-risk hormone IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Troponin I IVD, calibrator

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Troponin I IVD, control

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Vitamin B12 IVD, reagent

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Nasoenteral tube

Manufacturer:

Suzhou Yudu Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Single-administration urethral drainage catheter

Manufacturer:

Suzhou Yudu Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

General-purpose ultrasound imaging system

Manufacturer:

Teratech Corporation

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Endoscopic electrosurgical electrode, monopolar, single-use

Manufacturer:

Unimicro Medical Systems (Shenzhen) Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Tissue extraction bag

Manufacturer:

Unimicro Medical Systems (Shenzhen) Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

General-purpose syringe/needle

Manufacturer:

Vietnam Medical Plastic JSC

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible

Manufacturer:

Pihsiang Machinery Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

General-purpose ultrasound imaging system

Manufacturer:

Wuhan Zoncare Bio-medical Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Dental x-ray film, non-screen

Manufacturer:

Yestar (Guangxi) Medical System Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Adenovirus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Adenovirus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Adrenocorticotropic hormone (ACTH) IVD, calibrator

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Androstenedione IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Anti-Mullerian hormone (AMH) IVD, calibrator

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Bordetella pertussis immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Borrelia afzelii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Borrelia garinii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

NeoMedica doo

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Nasal oxygen cannula, basic

Manufacturer:

Suzhou Yudu Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Rectal medication/infusion catheter

Manufacturer:

Suzhou Yudu Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Laparoscopic access cannula, single-use

Manufacturer:

Unimicro Medical Systems (Shenzhen) Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Surgical irrigation tubing set, single-use

Manufacturer:

Unimicro Medical Systems (Shenzhen) Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Airway suction catheter

Manufacturer:

Vietnam Medical Plastic JSC

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Basic intravenous administration set, invasive

Manufacturer:

Vietnam Medical Plastic JSC

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Multi-purpose soft contact lens solution

Manufacturer:

Yung Sheng Optical Co. Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Soft corrective contact lens, daily-wear

Manufacturer:

Yung Sheng Optical Co. Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Electromechanical device/system transport trolley

Manufacturer:

Shanghai 3F Electronics Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Surgical/medical face mask, single-use

Manufacturer:

Shenzhen Yuzhan Precision Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Mobile/portable oxygen concentrator

Manufacturer:

SHENYANG AERTI TECH CO., LTD.

Type:

General Medical Device

Registration Date:

Mar 3, 2023

Knee support/thermal therapy bandage

Manufacturer:

Maverick Sports Medicine, Inc dba Pro-Tec Athletics

Type:

General Medical Device

Registration Date:

May 23, 2022

Wrist orthosis

Manufacturer:

Maverick Sports Medicine, Inc dba Pro-Tec Athletics

Type:

General Medical Device

Registration Date:

May 23, 2022

Elbow orthosis

Manufacturer:

Maverick Sports Medicine, Inc dba Pro-Tec Athletics

Type:

General Medical Device

Registration Date:

May 23, 2022

Calf/shin orthosis

Manufacturer:

Maverick Sports Medicine, Inc dba Pro-Tec Athletics

Type:

General Medical Device

Registration Date:

May 23, 2022

Back-filling orthosis

Manufacturer:

Maverick Sports Medicine, Inc dba Pro-Tec Athletics

Type:

General Medical Device

Registration Date:

May 23, 2022

Ankle/foot orthosis

Manufacturer:

Maverick Sports Medicine, Inc dba Pro-Tec Athletics

Type:

General Medical Device

Registration Date:

May 23, 2022

Dermatological frequency-doubled solid-state laser system

Manufacturer:

Beijing Sincoheren Science and Technology Development Co., Ltd.

Type:

General Medical Device

Registration Date:

Mar 21, 2022

Dermatological diode laser system

Manufacturer:

Beijing Sincoheren Science and Technology Development Co., Ltd.

Type:

General Medical Device

Registration Date:

Mar 21, 2022

Dermatological carbon dioxide laser system

Manufacturer:

Beijing Sincoheren Science and Technology Development Co., Ltd.

Type:

General Medical Device

Registration Date:

Mar 21, 2022

Penile ring

Manufacturer:

Pos-T-Vac LLC

Type:

General Medical Device

Registration Date:

Dec 13, 2021

Cartridge-accepting autoinjector, mechanical

Manufacturer:

Pos-T-Vac LLC

Type:

General Medical Device

Registration Date:

Dec 13, 2021

Penile vacuum device

Manufacturer:

Pos-T-Vac LLC

Type:

General Medical Device

Registration Date:

Dec 13, 2021

Incontinence penis clamp, reusable

Manufacturer:

Pos-T-Vac LLC

Type:

General Medical Device

Registration Date:

Dec 13, 2021

Blood pressure ambulatory recorder

Manufacturer:

Shenzhen Hingmed Medical Instrument Co., Ltd.

Type:

General Medical Device

Registration Date:

Oct 28, 2021

Isolation gown, single-use

Manufacturer:

Guangxi Zhongheng Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Mar 29, 2021

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Biotron Technology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Mar 24, 2021

Surgical/medical face mask, single-use

Manufacturer:

BEAR Medical Technology (Zhongshan) Co., Ltd

Type:

General Medical Device

Registration Date:

Mar 5, 2021

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Luoyang Ascend Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Dec 7, 2020

Magnetic particle separation instrument IVD

Manufacturer:

Luoyang Ascend Biotechnology Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Dec 7, 2020

Wheelchair, attendant/occupant-driven, bimanual-chain-operated, collapsible

Manufacturer:

Jiangsu Jumao x-care Medical Equipment Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 24, 2020

Wheelchair, occupant-driven, bimanual-chain-operated, collapsible

Manufacturer:

Jiangsu Jumao x-care Medical Equipment Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 24, 2020

Data sourced from the Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom.

Last updated: December 2025