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MT Promedt Consulting Ltd

Authorized Representative in the United Kingdom

Beaver House, 23-38 Hythe Bridge Street

Oxford, England, United Kingdom

Postcode: OX1 2EP

Relationship Type: UK Responsible Person
838 Products Represented
93 Manufacturers
Total Products
838
Manufacturers
93
Device Types
3
Generic Names
604
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (838)
Complete portfolio registered with MHRA

Laparoscopic motorized instrument control unit

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

N/A

Albumin IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chloride (Cl-) IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

High density lipoprotein (HDL) cholesterol IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyser IVD, laboratory

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Potassium (K+) IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sodium (Na+) IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total creatine kinase (CK) IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total protein IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urea IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Uric acid IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ambulatory insulin infusion pump reservoir gauge

Manufacturer:

SOOIL Development Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electric infusion pump administration set, single-use

Manufacturer:

SOOIL Development Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Alginate dental impression material

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, thermoplastic

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, thermoplastic

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental cotton roll

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental etching solution

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental impression tray, single-use

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental occlusal splint, customizable

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental occlusal splint, customizable

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental torque wrench

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental wedge, single-use

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held dental retractor

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic appliance dimension gauge

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic appliance relief material

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic archwire

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic bracket, ceramic

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic chin cap/cup

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic elastomeric appliance pusher

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic inter-bracket elastic chain

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic lock

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic pliers

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic rod-based aligner

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic separator

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Self-ligating orthodontic bracket

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anti-A red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-A red blood cell subtype differentiation reagent IVD

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-C [RH002] red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-C^w red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-K (KEL001) red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Wr^a red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cervical stiffness measurement system control unit

Manufacturer:

Pregnolia AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cervical stiffness measurement system probe

Manufacturer:

Pregnolia AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic endotracheal tube, single-use

Manufacturer:

SunMed LLC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laryngoscope handle, single-use

Manufacturer:

SunMed LLC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical eye pressure shield

Manufacturer:

SunMed LLC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SunMed LLC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic fundus camera

Manufacturer:

Forus Health Pvt. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Breathing circuit bag, single-use

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Breathing circuit catheter mount, single-use

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbon dioxide absorbent

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gas-sampling/monitoring respiratory tubing, single-use

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose patient temperature probe, reusable

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heat/moisture exchanger, single-use

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laryngeal mask airway, single-use

Manufacturer:

Cookgas LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, resin

Manufacturer:

DENTCA, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

MRI system coil, radio-frequency

Manufacturer:

RAPID Biomedical GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluid transfer set, general-purpose

Manufacturer:

PMT prรคzision.medizin.technik. GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

MRI system coil, radio-frequency

Manufacturer:

RAPID Biomedical GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Glaucoma shunt

Manufacturer:

Advanced Ophthalmic Innovations Pte. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Clavicle orthosis

Manufacturer:

OPPO Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hip/knee/ankle/foot orthosis

Manufacturer:

OPPO Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Shoulder/elbow/wrist/hand orthosis

Manufacturer:

OPPO Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anti-A red blood cell grouping IVD, antibody

Manufacturer:

Dominion Biologicals Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-B red blood cell grouping IVD, antibody

Manufacturer:

Dominion Biologicals Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-C [RH002] red blood cell grouping IVD, antibody

Manufacturer:

Dominion Biologicals Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-C [RH004] red blood cell grouping IVD, antibody

Manufacturer:

Dominion Biologicals Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Polyspecific antihuman globulin IVD, antibody

Manufacturer:

Dominion Biologicals Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Kp^a red blood cell grouping IVD, antibody

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Benchtop nebulizer, non-heated

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Capnography oxygen mask

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gas-sampling/monitoring respiratory tubing, single-use

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oxygen administration tubing

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Respiratory apnoea monitoring system

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin-cover adhesive strip, non-antimicrobial

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lumbosacral spine orthosis, pendulous abdomen support

Manufacturer:

La Pointique Int'l Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Shoulder/elbow/wrist/hand orthosis

Manufacturer:

La Pointique Int'l Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Catheter injection port

Manufacturer:

Epic International (Thailand) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Luer/Luer linear connector, single-use

Manufacturer:

Epic International (Thailand) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vial/bottle adaptor, non-hermetic

Manufacturer:

Epic International (Thailand) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, ear/skin

Manufacturer:

Radiant Innovation Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, skin

Manufacturer:

Radiant Innovation Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiograph, professional, single-channel

Manufacturer:

ATsens Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic spectral-domain optical coherence tomography system

Manufacturer:

Cylite Pty Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Resin artificial teeth

Manufacturer:

DENTCA, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held ultrasound imaging system, body-surface

Manufacturer:

PulseNmore Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tissue cryostorage straw

Manufacturer:

REPROLIFE Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Glaucoma shunt

Manufacturer:

Advanced Ophthalmic Innovations Pte. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Albumin/creatinine ratio (ACR) IVD, reagent

Manufacturer:

i-SENS, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose monitoring system IVD, home-use

Manufacturer:

i-SENS, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, control

Manufacturer:

i-SENS, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ketone (acetoacetate) IVD, control

Manufacturer:

i-SENS, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ketone (acetoacetate) IVD, reagent

Manufacturer:

i-SENS, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Manufacturer:

i-SENS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, control

Manufacturer:

Lumos Diagnostic, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Blood gas analyser IVD, laboratory, semi-automated

Manufacturer:

OPTI Medical Systems, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Princeton BioMeditech Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, kit, rapid ICT, clinical

Manufacturer:

Princeton BioMeditech Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, kit, rapid ICT, clinical

Manufacturer:

Princeton BioMeditech Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methamphetamine-specific IVD, kit, rapid ICT, clinical

Manufacturer:

Princeton BioMeditech Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Princeton BioMeditech Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Photometric/spectroscopic immunoassay analyser IVD

Manufacturer:

Princeton BioMeditech Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Platelet aggregation study IVD, kit, nephelometry/turbidimetry

Manufacturer:

Takeda Austria GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cryolipolysis body contouring system

Manufacturer:

CLASSYS Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical assistive bed

Manufacturer:

ISKO KOCH GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental power tool system handpiece, pneumatic

Manufacturer:

J. MORITA MFG. CORP.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stationary panoramic/tomographic dental x-ray system, digital

Manufacturer:

J. MORITA MFG. CORP.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lipase IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total alkaline phosphatase (ALP) IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total amylase IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hand-held surgical retractor, reusable

Manufacturer:

Yasui Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile examination/treatment room light

Manufacturer:

Yasui Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anti-B red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-C [RH004] red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-CDE red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-E [RH003] red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-M red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-N red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Rh(D) red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Blood group/antibody screening analyser IVD

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered isotonic saline reagent IVD

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gastro-oesophageal antireflux extraluminal fundal implant

Manufacturer:

Implantica CE Reflux Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gastro-oesophageal antireflux fundal implant placement tool, reusable

Manufacturer:

Implantica CE Reflux Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multiplex analyser IVD, laboratory

Manufacturer:

Sugentech, 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:

Sugentech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing

Manufacturer:

Sugentech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated

Manufacturer:

Vela Operations Singapore Pte. Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anaesthesia breathing circuit, single-use

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbon dioxide absorbent cartridge

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbon dioxide absorber, single-use

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic lead set, reusable

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic lead set, single-use

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic lead switching adaptor

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic recording paper

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foetal scalp electrode, spiral

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heat/moisture exchanger/microbial medical gas filter

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Microbial medical gas filter, single-use

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological general body-part positioner

Manufacturer:

ALCARE Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Alginate dental impression material

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental spatula, reusable

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental unfilled resin sealant/coating

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic archwire protection sleeve

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic archwire/bracket ligature

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic bracket adhesive

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic bracket, metal

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic inter-arch elastic band

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic ligature director

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic metal band

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic metal band pusher

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic retainer

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic spring

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic tube

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Self-ligating orthodontic bracket open/close tool

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Self-ligating orthodontic bracket open/close tool

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Zika virus antigen IVD, kit, fluorescent immunoassay, rapid

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Zika virus immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Zika virus immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

External limb prosthesis socket liner

Manufacturer:

Swiss Motion Technologies SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anti-Mi^a red blood cell gouping IVD, antibody

Manufacturer:

Dominion Biologicals Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Rh(D) red blood cell grouping IVD, antibody

Manufacturer:

Dominion Biologicals Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antisera matrix (non-reactive) IVD, control

Manufacturer:

Dominion Biologicals Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Endoscope sheath, reusable

Manufacturer:

Henke-Sass, Wolf GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid sinoscope

Manufacturer:

Henke-Sass, Wolf GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anti-AB red blood cell grouping IVD, antibody

Manufacturer:

Dominion Biologicals Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-E [RH005] red blood cell grouping IVD, antibody

Manufacturer:

Dominion Biologicals Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Monospecific anti-complement component C3d (anti-C3d) IVD, antibody

Manufacturer:

Dominion Biologicals Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody

Manufacturer:

Dominion Biologicals Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Fy^b red blood cell grouping IVD, antibody

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-k (KEL002) red blood cell grouping IVD, antibody

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-S [MNS003] red blood cell grouping IVD, antibody

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-S [MNS004] red blood cell grouping IVD, antibody

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bovine serum albumin (BSA) immunohaematology reagent IVD

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered isotonic saline reagent IVD

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cell preservation/storage/dilution solution IVD

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) immunoglobulin G (IgG)/IgM antibody IVD, kit, solid-phase red blood cell adherence

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human platelet antigen (HPA) multiple antibody screening/identification IVD, control

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunohaematology/blood bank analyser IVD

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lewis blood group substance reagent IVD

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microplate IVD

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Monospecific anti-complement component C3d (anti-C3d) IVD, antibody

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

P1 blood group substance reagent IVD

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Papain immunohaematology reagent IVD

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Polyspecific antihuman globulin/complement IVD, antibody

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General-purpose syringe, single-use

Manufacturer:

Henke-Sass, Wolf GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose syringe/needle

Manufacturer:

Henke-Sass, Wolf GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Otoscope, endoscopic

Manufacturer:

Henke-Sass, Wolf GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid arthroscope, reusable

Manufacturer:

Henke-Sass, Wolf GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid optical laparoscope

Manufacturer:

Henke-Sass, Wolf GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Seegene Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

MDR-TB/XDR-TB nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Seegene Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

MERS-CoV nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Seegene Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Seegene Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Seegene Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Seegene Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Seegene Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type vaginitis-associated organism nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Seegene Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycoplasma genitalium nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Seegene Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Seegene Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid sample preparation instrument IVD

Manufacturer:

Seegene Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Seegene Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza virus/respiratory syncytial virus (RSV) antigen IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

MDR-TB/XDR-TB nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microalbumin IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum total antibody IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Capillary blood collection tube IVD, no additive

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chikungunya virus immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatine kinase myocardial isoenzyme (CKMB) IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus antigen/antibody IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus NS1 antigen IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ebola virus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Evacuated blood collection tube IVD, anticoagulant

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fluorescent immunoassay analyser IVD, laboratory, semi-automated

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Follicle stimulating hormone (FSH) IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen container IVD, no additive/medium

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose analyser IVD, home-use

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose IVD, reagent

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, kit, fluorescent immunoassay, rapid

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

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:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza A/B virus antigen IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza A/B virus antigen IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy vitamin D IVD, kit, fluorescent immunoassay, rapid

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple tropical viral pathogen antigen/antibody IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple vector-borne pathogen immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycobacterium tuberculosis complex species antigen IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alanine aminotransferase (ALT) IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Norovirus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Orientia tsutsugamushi immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Respiratory syncytial virus (RSV) antigen IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rotavirus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 antigen IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 neutralizing antibody IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sputum specimen liquefaction/decontamination kit IVD

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sputum specimen liquefaction/decontamination kit IVD

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Streptococcus pneumoniae antigen IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total thyroxine (TT4) IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin I IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microarray analyser IVD

Manufacturer:

BioArray Solutions Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIONEER Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

BIONEER Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

BIONEER Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

BIONEER Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIONEER Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

BIONEER Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid sample preparation instrument IVD

Manufacturer:

BIONEER Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid sample preparation instrument IVD

Manufacturer:

BIONEER Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

BIONEER Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clinical periodontal dressing

Manufacturer:

GluStitch Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mycoplasma pneumoniae antigen IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Self-care monitoring/reporting software

Manufacturer:

Oviva AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

CD34 cell marker IVD, antibody

Manufacturer:

NanoEnTek Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cervical spine collar, reusable

Manufacturer:

La Pointique Int'l Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Clavicle orthosis

Manufacturer:

La Pointique Int'l Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hot/cold therapy pack, reusable

Manufacturer:

La Pointique Int'l Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Chlamydia trachomatis nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Bosch Healthcare Solutions GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bosch Healthcare Solutions GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bosch Healthcare Solutions GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bosch Healthcare Solutions GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-genus sexually transmitted bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Bosch Healthcare Solutions GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bosch Healthcare Solutions GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bosch Healthcare Solutions GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clinical management support software

Manufacturer:

Baxalta US Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Princeton BioMeditech Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Princeton BioMeditech Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid

Manufacturer:

Princeton BioMeditech Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, resin

Manufacturer:

Asiga

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental handpiece maintenance unit

Manufacturer:

J. MORITA MFG. CORP.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic apex locator

Manufacturer:

J. MORITA MFG. CORP.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Apheresis system filter, whole blood

Manufacturer:

SB-KAWASUMI LABORATORIES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

nerbe plus GmbH & Co KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

KH Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cell morphology analyser IVD, manual

Manufacturer:

Konan Medical, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cartridge-accepting autoinjector, mechanical

Manufacturer:

Takeda Pharmaceuticals U.S.A. Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cartridge-accepting autoinjector, mechanical

Manufacturer:

Takeda Pharmaceuticals U.S.A. Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose syringe, single-use

Manufacturer:

Takeda Pharmaceuticals U.S.A. Inc.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Thermometric fertility analyser

Manufacturer:

TEMPDROP LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile general-purpose fluoroscopic x-ray system, digital

Manufacturer:

Turner Imaging Systems, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile medical equipment stand, non-powered

Manufacturer:

Turner Imaging Systems, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental diode laser system

Manufacturer:

Biolase, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental solid-state laser system

Manufacturer:

Biolase, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental surgical laser system beam guide

Manufacturer:

Biolase, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient monitoring system module, data memory

Manufacturer:

Visionflex Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cervical spine collar, reusable

Manufacturer:

OPPO Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hot/cold therapy pack, reusable

Manufacturer:

OPPO Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Triglyceride IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General-purpose syringe, reusable

Manufacturer:

Henke-Sass, Wolf GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hypodermic needle, single-use

Manufacturer:

Henke-Sass, Wolf GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid optical hysteroscope

Manufacturer:

Henke-Sass, Wolf GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Immucor GTI Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HLA class I & II antigen tissue typing IVD, kit, multiplex

Manufacturer:

Immucor GTI Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HLA class I antibody screening IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immucor GTI Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immucor GTI Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose monitoring system IVD, home-use

Manufacturer:

MiCo BioMed Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple lipid analyte IVD, kit, colorimetric, rapid, professional/self-test

Manufacturer:

MiCo BioMed 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:

MiCo BioMed Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cholesterol lipid IVD, reagent

Manufacturer:

MiCo BioMed Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Seegene Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Seegene Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Seegene Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Seegene Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Seegene Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Seegene Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Seegene Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Seegene Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adenovirus antigen IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Albumin IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD, manual

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal specimen container IVD, transport buffer/medium

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fluorescent immunoassay analyser IVD, laboratory, semi-automated

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fluorescent immunoassay analyser IVD, point-of-care

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free thyroxine (FT4) IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose/ketone/lipid profile IVD, reagent

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, kit, fluorescent immunoassay, rapid

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interferon gamma release IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interferon IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Legionella pneumophila antigen IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple gastrointestinal virus antigen IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple tropical viral pathogen immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycoplasma pneumoniae antigen IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycoplasma pneumoniae total antibody IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

PCR instrument calibrator kit IVD

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prolactin IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme spectrophotometry

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Streptococcus pneumoniae antigen IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, point-of-care

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total triiodothyronine (TT3) IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum total antibody IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin I IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood group genotyping IVD, reagent

Manufacturer:

BioArray Solutions Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

Data Innovations LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Isothermal nucleic acid amplification analyser IVD, point-of-care

Manufacturer:

Diagnostics for the Real World Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple human platelet antigen (HPA) typing IVD, kit, multiplex

Manufacturer:

Immucor GTI Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Platelet factor 4 IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Immucor GTI Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose IVD, reagent

Manufacturer:

MiCo BioMed Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Asan 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:

Asan Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Diagnostics for the Real World Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Diagnostics for the Real World Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Wuchereria bancrofti antigen IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Vela Operations Singapore Pte. Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Vela Operations Singapore Pte. Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1 genotyping IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Vela Operations Singapore Pte. Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human herpesvirus 6 (HHV6) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Vela Operations Singapore Pte. Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)

Manufacturer:

Vela Operations Singapore Pte. Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Skin abrasion unit

Manufacturer:

CLASSYS Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/emergency suction cannula, non-illuminating, single-use

Manufacturer:

CLASSYS Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Freestanding patient lifting system, electrically-powered

Manufacturer:

ISKO KOCH GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbon dioxide absorber, single-use

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic electrode connector

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic electrode, single-use

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose patient temperature probe, single-use

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Injectate temperature probe

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiolucent electrocardiographic lead

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Elastomeric infusion pump system

Manufacturer:

Epic International (Thailand) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Luer/non-ISO80369-standardized linear connector, single-use

Manufacturer:

Epic International (Thailand) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-ISO80369 formatted bag access spike

Manufacturer:

Epic International (Thailand) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-ISO80369-standardized small-bore linear connector, single-use

Manufacturer:

Epic International (Thailand) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Irrigation syringe

Manufacturer:

Ethox Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General/multiple surgical laser system beam guide, reusable

Manufacturer:

Eufoton S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General/multiple surgical laser system beam guide, single-use

Manufacturer:

Eufoton S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical laser system fibreoptic cable

Manufacturer:

Eufoton S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatinine IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calcium (Ca2+) IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Conjugated (direct) bilirubin IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gamma-glutamyltransferase (GGT) IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inorganic phosphate (PO43-) IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyser IVD, laboratory

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total aspartate aminotransferase (AST) IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total bilirubin IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cholesterol lipid IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total lactate dehydrogenase (LDH) IVD, reagent

Manufacturer:

SKYLA CORPORATION HSINCHU SCIENCE PARK BRANCH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ear canal irrigation syringe

Manufacturer:

Henke-Sass, Wolf GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Subcutaneous infusion/injection port needle

Manufacturer:

Shire Human Genetic Therapies, Inc. (Shire HGT)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluid transfer set, general-purpose

Manufacturer:

Shire Human Genetic Therapies, Inc. (Shire HGT)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytological centrifuge funnel IVD

Manufacturer:

ELITech Group Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Osmolality IVD, calibrator

Manufacturer:

ELITech Group Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Osmometric analyser IVD

Manufacturer:

ELITech Group Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sweat conductivity analyser IVD

Manufacturer:

ELITech Group Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ambulatory insulin infusion pump, electronic, non-software-dosing

Manufacturer:

SOOIL Development Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Angiography contrast medium injection system, battery-powered

Manufacturer:

MEDTRON AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Angiography contrast medium injection system, line-powered, stationary

Manufacturer:

MEDTRON AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Contrast medium injection system syringe

Manufacturer:

MEDTRON AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiographic procedure tubing

Manufacturer:

MEDTRON AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electronic thermometer probe cover

Manufacturer:

Radiant Innovation Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, ear

Manufacturer:

Radiant Innovation Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foot friction/impact protector

Manufacturer:

La Pointique Int'l Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hip/knee/ankle/foot orthosis

Manufacturer:

La Pointique Int'l Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suspension arm sling

Manufacturer:

La Pointique Int'l Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood pressure cuff, reusable

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal oxygen cannula, basic

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal oxygen cannula, carbon-dioxide-sampling

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Respiratory apnoea monitoring system

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin-cover adhesive strip, non-antimicrobial

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Perineometer

Manufacturer:

Stratos MedTech Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held surgical retractor, single-use

Manufacturer:

Yasui Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Temporary dental crown/bridge resin

Manufacturer:

DENTCA, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Coagulation factor VIII IVD, antibody

Manufacturer:

Shire Human Genetic Therapies, Inc. (Shire HGT)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin I IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, ear

Manufacturer:

Radiant Innovation Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, ear/skin

Manufacturer:

Radiant Innovation Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, skin

Manufacturer:

Radiant Innovation Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haptoglobin IVD, kit, precipitation/immunodiffusion

Manufacturer:

INEX Innovate Pte Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care

Manufacturer:

i-SENS, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose IVD, control

Manufacturer:

i-SENS, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose IVD, reagent

Manufacturer:

i-SENS, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose monitoring system IVD, home-use

Manufacturer:

i-SENS, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Manual blood lancing device, reusable

Manufacturer:

i-SENS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Metabolic profile clinical chemistry analyser IVD

Manufacturer:

i-SENS, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

Manufacturer:

i-SENS, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyte monitoring system IVD, home-use

Manufacturer:

i-SENS, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Self-care monitoring/reporting software

Manufacturer:

i-SENS, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multiple cell-mediated host immune response marker IVD, kit, rapid ICT, clinical

Manufacturer:

Lumos Diagnostic, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen microscopy slide IVD, single-use

Manufacturer:

Matsunami Glass Ind., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amphetamine-specific IVD, kit, rapid ICT, clinical

Manufacturer:

Princeton BioMeditech Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cotinine IVD, kit, rapid ICT, clinical

Manufacturer:

Princeton BioMeditech Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Princeton BioMeditech Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Morphine/morphine metabolite IVD, kit, rapid ICT, clinical

Manufacturer:

Princeton BioMeditech Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sperm concentration indicator IVD, kit, rapid ICT, self-testing

Manufacturer:

Princeton BioMeditech Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Contrast medium injection system control unit

Manufacturer:

MEDTRON AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Contrast medium injection system control unit

Manufacturer:

MEDTRON AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

CT contrast medium injection system, battery-powered

Manufacturer:

MEDTRON AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

CT contrast medium injection system, line-powered, stationary

Manufacturer:

MEDTRON AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrochemical breath analyser filter/mouthpiece IVD

Manufacturer:

Bosch Healthcare Solutions GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Electrochemical breath analyser IVD, home-use

Manufacturer:

Bosch Healthcare Solutions GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Electrochemical breath analyser IVD, point-of-care

Manufacturer:

Bosch Healthcare Solutions GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bosch Healthcare Solutions GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-E [RH003] red blood cell grouping IVD, antibody

Manufacturer:

Dominion Biologicals Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Jk^a red blood cell grouping IVD, antibody

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Kp^b red blood cell grouping IVD, antibody

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Le^b red blood cell grouping IVD, antibody

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bromelin immunohaematology reagent IVD

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) total antibody IVD, control

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytomegalovirus (CMV) total antibody IVD, reagent

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ficin immunohaematology reagent IVD

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Foeto-maternal haemorrhage/Kleihauer test IVD, reagent

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Low ionic-strength salt solution (LISS) immunohaematology reagent IVD

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple immunohaematology test IVD, control

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple immunohaematology test IVD, control

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Polyethylene glycol (PEG) immunohaematology reagent IVD

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pooled antibody screening reagent red blood cell IVD, antigen

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation factor VIII IVD, kit, chromogenic

Manufacturer:

Immucor GTI Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Complement reagent IVD

Manufacturer:

Immucor GTI Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HLA class II antigen tissue typing IVD, kit, multiplex

Manufacturer:

Immucor GTI Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, multiplex

Manufacturer:

Immucor GTI Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

Immucor GTI Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple lipid analyte IVD, reagent

Manufacturer:

MiCo BioMed Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Arthroscopic obturator

Manufacturer:

Henke-Sass, Wolf GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oral/upper respiratory tract specimen collection kit IVD, clinical

Manufacturer:

Asan Pharmaceutical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Caris MPI, Inc. D/B/A Caris Life Sciences

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clinical laboratory information system application software

Manufacturer:

Data Innovations LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Diagnostics for the Real World Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Immucor GTI Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HLA class I antigen tissue typing IVD, kit, multiplex

Manufacturer:

Immucor GTI Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Surgical instrument maintenance lubricant

Manufacturer:

J. MORITA MFG. CORP.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Autologous conditioned serum syringe

Manufacturer:

Rhein Device GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Apheresis system filter, plasma

Manufacturer:

SB-KAWASUMI LABORATORIES, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye anterior segment analyser

Manufacturer:

Konan Medical, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-purpose digital medical camera

Manufacturer:

Visionflex Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haematological cell analyser IVD

Manufacturer:

NanoEnTek Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope counting chamber IVD

Manufacturer:

NanoEnTek Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-C^w red blood cell grouping IVD, antibody

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Fy^a red blood cell grouping IVD, antibody

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Jk^b red blood cell grouping IVD, antibody

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Le^a red blood cell grouping IVD, antibody

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antibody identification panel reagent red blood cell IVD, kit, agglutination

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antibody screening reagent red blood cell IVD, kit, agglutination

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD, automated/semi-automated system

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunoglobulin-sensitized reagent red blood cell IVD, control

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple immunohaematology test IVD, control

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Red cell antibody eluting IVD, kit

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Solid-phase red blood cell adherence antibody/antigen IVD

Manufacturer:

Immucor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vial/bottle adaptor, hermetic

Manufacturer:

Epic International (Thailand) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous pressure infusor, manual, reusable

Manufacturer:

Ethox Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument interim-placement holder, single-use

Manufacturer:

Ethox Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General/multiple surgical laser system beam guide, reusable

Manufacturer:

Eufoton S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Aneroid manual sphygmomanometer

Manufacturer:

MDF Instruments Medifriend Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Percussion hammer, manual, reusable

Manufacturer:

MDF Instruments Medifriend Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Biological stain control IVD

Manufacturer:

ELITech Group Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Biological stain IVD

Manufacturer:

ELITech Group Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chloride (Cl-) IVD, calibrator

Manufacturer:

ELITech Group Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Erythrocyte sedimentation rate (ESR) IVD, control

Manufacturer:

ELITech Group Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide stainer IVD

Manufacturer:

ELITech Group Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Osmolality IVD, control

Manufacturer:

ELITech Group Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sweat-induction iontophoresis device/conductivity analyser

Manufacturer:

ELITech Group Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Angiography contrast medium injection system, line-powered, mobile

Manufacturer:

MEDTRON AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

CT contrast medium injection system, line-powered, mobile

Manufacturer:

MEDTRON AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluid transfer set, general-purpose

Manufacturer:

MEDTRON AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose syringe, single-use

Manufacturer:

MEDTRON AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

MRI contrast medium injection system, battery-powered

Manufacturer:

MEDTRON AG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sugentech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sugentech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical

Manufacturer:

Sugentech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sugentech, 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:

Sugentech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Vela Operations Singapore Pte. Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus genotyping IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Vela Operations Singapore Pte. Ltd.

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:

Vela Operations Singapore Pte. Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Vela Operations Singapore Pte. Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid sample preparation instrument IVD

Manufacturer:

Vela Operations Singapore Pte. Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Varicella-zoster virus (VZV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Vela Operations Singapore Pte. Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gastro-oesophageal antireflux extraluminal fundal implant

Manufacturer:

Implantica CE Reflux Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cryolipolysis body contouring system gel pad

Manufacturer:

CLASSYS Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasonic hyperthermia system

Manufacturer:

CLASSYS Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental power tool system handpiece, battery-powered

Manufacturer:

J. MORITA MFG. CORP.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental power tool system handpiece, line-powered

Manufacturer:

J. MORITA MFG. CORP.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Remotely-driven dental drilling system motor

Manufacturer:

J. MORITA MFG. CORP.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic fixation plate, non-bioabsorbable

Manufacturer:

INTERCUS GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mechanical stethoscope

Manufacturer:

MDF Instruments Medifriend Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Chloride coulometric titration analyser IVD, semi-automated

Manufacturer:

ELITech Group Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytological centrifuge IVD

Manufacturer:

ELITech Group Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Evacuated erythrocyte sedimentation rate (ESR) tube IVD

Manufacturer:

ELITech Group Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple electrolyte IVD, calibrator

Manufacturer:

ELITech Group Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, control

Manufacturer:

ELITech Group Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sweat-induction iontophoresis system

Manufacturer:

ELITech Group Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sweat-induction iontophoresis system

Manufacturer:

ELITech Group Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ELITech Group Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gastric lavage kit

Manufacturer:

Ethox Medical, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General/multiple surgical diode laser system

Manufacturer:

Eufoton S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General/multiple surgical laser system beam guide, reusable

Manufacturer:

Eufoton S.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile/portable oxygen concentrator

Manufacturer:

O2 Concepts

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluorescent immunoassay analyser IVD, point-of-care

Manufacturer:

NanoEnTek Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

White blood cell count IVD, kit, cell count

Manufacturer:

NanoEnTek Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ambulatory insulin infusion pump reservoir

Manufacturer:

SOOIL Development Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infusion pump medication-dosage application software

Manufacturer:

SOOIL Development Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Insulin infusion cannula introducer

Manufacturer:

SOOIL Development Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Perineometer

Manufacturer:

Stratos MedTech Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urinary incontinence self-treatment software

Manufacturer:

Stratos MedTech Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood gas syringe/needle, lithium heparin

Manufacturer:

SunMed LLC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Automated ophthalmic refractometer

Manufacturer:

Forus Health Pvt. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic fundus camera

Manufacturer:

Forus Health Pvt. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Manufacturer:

INTERCUS GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental diode laser system

Manufacturer:

Biolase, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermatological laser beam guiding handpiece

Manufacturer:

Biolase, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General/multiple surgical diode laser system

Manufacturer:

Biolase, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Musculoskeletal/physical therapy laser beam guide, transcutaneous

Manufacturer:

Biolase, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood gas syringe IVD, lithium heparin

Manufacturer:

Westmed Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Medical/surgical interventional tube/cable securement strap

Manufacturer:

Westmed Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cartridge-accepting autoinjector, mechanical

Manufacturer:

Shire Pharmaceuticals Ireland Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cell culture medium IVD

Manufacturer:

nerbe plus GmbH & Co KG

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Abdominal hernia truss, reusable

Manufacturer:

OPPO Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foot friction/impact protector

Manufacturer:

OPPO Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lumbosacral spine orthosis, pendulous abdomen support

Manufacturer:

OPPO Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suspension arm sling

Manufacturer:

OPPO Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Seegene Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adenovirus antigen IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus antigen IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus antigen IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clostridium difficile antigen IVD, kit, fluorescent immunoassay, rapid

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus NS1 antigen IVD, reagent

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fluorescent immunoassay analyser IVD, point-of-care

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free thyroxine (FT4) IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose/ketone/lipid profile IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haemoglobin/glucose-6-phosphate dehydrogenase (G6PD) analyser IVD

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interferon gamma release IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Legionella pneumophila antigen IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Legionella pneumophila antigen IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Luteinizing hormone (LH) IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Luteinizing hormone (LH) IVD, kit, fluorescent immunoassay, rapid

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microplate/tube/assay card incubator IVD

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Leptospira species immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple mosquito-borne flavivirus immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple tropical viral pathogen antigen/antibody IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type gastrointestinal pathogen antigen IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycobacterium tuberculosis complex species antigen IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycoplasma pneumoniae total antibody IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Norovirus antigen IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Norovirus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Orientia tsutsugamushi immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Plasmodium falciparum antigen IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, 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:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2/influenza A/B antigen IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid stimulating hormone (TSH) IVD, control

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cholesterol lipid IVD, reagent

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total thyroxine (TT4) IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total triiodothyronine (TT3) IVD, kit, fluorescent immunoassay

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum total antibody IVD, kit, rapid ICT, clinical

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Triglyceride IVD, reagent

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HLA class I & II antigen tissue typing IVD, kit, multiplex

Manufacturer:

BioArray Solutions Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood group genotyping IVD, reagent

Manufacturer:

BioArray Solutions Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

BIONEER Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

BIONEER Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Albumin/creatinine ratio (ACR) IVD, control

Manufacturer:

i-SENS, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care

Manufacturer:

i-SENS, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, reagent

Manufacturer:

i-SENS, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Metabolic profile clinical chemistry analyser IVD

Manufacturer:

i-SENS, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

Manufacturer:

i-SENS, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyte monitoring system IVD, home-use

Manufacturer:

i-SENS, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sugentech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid

Manufacturer:

Sugentech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Photometric/spectroscopic immunoassay analyser IVD

Manufacturer:

Sugentech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyser IVD, laboratory

Manufacturer:

Tokyo Boeki Medisys Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gastro-oesophageal antireflux extraluminal fundal implant

Manufacturer:

Implantica CE Reflux Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anti-A1 red blood cell grouping IVD, lectin

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-E [RH005] red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-H red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-P1 red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-S [MNS003] red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-S [MNS004] red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple immunohaematology test IVD, control

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Polyspecific antihuman globulin/complement IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bite registration rim wax, plate

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bite relief pad

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental cheek retractor, professional, reusable

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental cotton roll

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental mirror, reusable

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic palate expander/teeth aligner, bonded

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic power arm

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic wire

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tongue-training dental orthosis

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Bosch Healthcare Solutions GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Electrochemical breath analyser filter/mouthpiece IVD

Manufacturer:

Bosch Healthcare Solutions GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Electrochemical breath analysis system IVD

Manufacturer:

Bosch Healthcare Solutions GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Bosch Healthcare Solutions GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

Bosch Healthcare Solutions GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cranial trephine, single-use

Manufacturer:

ACRA-CUT, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Aerosol face mask, non-rebreathing

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood pressure cuff, reusable

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood pressure cuff, single-use

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gas-sampling/monitoring respiratory tubing, single-use

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous pressure infusor, manual, reusable

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-heated respiratory humidifier

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-rebreathing oxygen face mask

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic intravenous administration set, noninvasive

Manufacturer:

Epic International (Thailand) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous administration bag/bottle

Manufacturer:

Epic International (Thailand) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous administration tubing extension set

Manufacturer:

Epic International (Thailand) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Luer-formatted bag access spike

Manufacturer:

Epic International (Thailand) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Neutral-pressure intravenous line needleless valve-connector

Manufacturer:

Epic International (Thailand) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-ISO80369-standardized fluid path protective cover

Manufacturer:

Epic International (Thailand) Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Wiener Laboratorios S.A.I.C

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Glucose IVD, reagent

Manufacturer:

All Medicus Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 1, 2024

Glucose monitoring system IVD, home-use

Manufacturer:

All Medicus Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 1, 2024

Glucose IVD, control

Manufacturer:

All Medicus Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 1, 2024

Nasal oxygen cannula, carbon-dioxide-sampling

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Straight/elbow breathing circuit connector, single-use

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Sep 24, 2024

General specimen container IVD, no additive/medium

Manufacturer:

nerbe plus GmbH & Co KG

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Gas dehumidification tubing set, single-use

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Inspiratory/expiratory limb respiratory tubing, reusable

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Carbon dioxide cuvette, single-use

Manufacturer:

AirLife Finland Oy

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Oral/respiratory tract specimen container IVD, additive/medium

Manufacturer:

MiCo BioMed Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 8, 2024

Thermal cycler nucleic acid amplification instrument IVD, manual

Manufacturer:

MiCo BioMed Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 8, 2024

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

Manufacturer:

MiCo BioMed Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 8, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

MiCo BioMed Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 8, 2024

Nucleic acid sample preparation instrument IVD

Manufacturer:

MiCo BioMed Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 8, 2024

Visual evoked-potential graphic recorder

Manufacturer:

Konan Medical USA, Inc.

Type:

General Medical Device

Registration Date:

Jun 17, 2024

Non-rebreathing oxygen face mask

Manufacturer:

Ventlab LLC.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

YAMAKIN CO., LTD.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Dental prosthesis veneer resin

Manufacturer:

YAMAKIN CO., LTD.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Pulmonary resuscitator, manual, single-use

Manufacturer:

Ventlab LLC.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Nasal oxygen cannula, basic

Manufacturer:

Ventlab LLC.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Aerosol face mask, non-rebreathing

Manufacturer:

Ventlab LLC.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Respiratory sound analysis software, professional-only

Manufacturer:

ResApp Health Limited

Type:

General Medical Device

Registration Date:

Feb 23, 2024

Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)

Manufacturer:

Vela Operations Singapore Pte. Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 24, 2023

Nucleic acid sample preparation instrument IVD

Manufacturer:

Vela Operations Singapore Pte. Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 24, 2023

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Vela Operations Singapore Pte. Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 24, 2023

Orthodontic bracket adhesive

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Dental etching solution

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Orthodontic archwire

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Orthodontic archwire protection sleeve

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Orthodontic bracket, metal

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Orthodontic metal band

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Orthodontic metal band pusher

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Orthodontic palate expander/teeth aligner, bonded

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Orthodontic power arm

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Orthodontic separator

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Orthodontic wire

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Self-ligating orthodontic bracket

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Tongue-training dental orthosis

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Orthodontic bracket, ceramic

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Orthodontic inter-arch elastic band

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Orthodontic inter-bracket elastic chain

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Orthodontic lock

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Orthodontic pliers

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Orthodontic rod-based aligner

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Orthodontic spring

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Orthodontic tube

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Carbide dental bur, reusable

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Dental occlusal splint, customizable

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Dental spatula, reusable

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Dental surgical probe, reusable

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Dental unfilled resin sealant/coating

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Orthodontic archwire/bracket ligature

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Orthodontic retainer

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Diamond dental bur, reusable

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Orthodontic bracket, plastic, single-use

Manufacturer:

American Orthodontics Corp

Type:

General Medical Device

Registration Date:

Mar 4, 2022

Multiple clinical chemistry analyser IVD, laboratory

Manufacturer:

Tokyo Boeki Medisys Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 19, 2022

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

Manufacturer:

Noble Biosciences, Inc.

Type:

General Medical Device

Registration Date:

Dec 30, 2021

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

Manufacturer:

DxGen Corp.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 25, 2021

Nasal oxygen cannula, basic

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Aug 25, 2021

Non-rebreathing oxygen face mask

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Aug 25, 2021

Non-heated respiratory humidifier

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Aug 25, 2021

Intravenous pressure infusor, manual, reusable

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Aug 25, 2021

Nasal oxygen cannula, carbon-dioxide-sampling

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Aug 25, 2021

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

Manufacturer:

DxGen Corp.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 25, 2021

Aerosol face mask, non-rebreathing

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Aug 25, 2021

Oxygen administration tubing

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Aug 25, 2021

Benchtop nebulizer, non-heated

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Aug 25, 2021

Capnography oxygen mask

Manufacturer:

Salter Labs

Type:

General Medical Device

Registration Date:

Aug 25, 2021

Dental anaesthesia syringe, intraligamentary

Manufacturer:

Henke-Sass, Wolf GmbH

Type:

General Medical Device

Registration Date:

Aug 20, 2021

Dental impression material syringe, reusable

Manufacturer:

Henke-Sass, Wolf GmbH

Type:

General Medical Device

Registration Date:

Aug 20, 2021

Biological stain control IVD

Manufacturer:

ELITech Group Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 17, 2021

Microscope slide stainer IVD

Manufacturer:

ELITech Group Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 17, 2021

Biological stain IVD

Manufacturer:

ELITech Group Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 17, 2021

Electronic stethoscope

Manufacturer:

Thinklabs Medical LLC

Type:

General Medical Device

Registration Date:

Aug 16, 2021

X-ray image interpretive software

Manufacturer:

Lunit Inc.

Type:

General Medical Device

Registration Date:

Aug 4, 2021

X-ray image interpretive software

Manufacturer:

Lunit Inc.

Type:

General Medical Device

Registration Date:

Aug 4, 2021

X-ray image interpretive software

Manufacturer:

Lunit Inc.

Type:

General Medical Device

Registration Date:

Aug 4, 2021

Contrast medium injection system control unit

Manufacturer:

MEDTRON AG

Type:

General Medical Device

Registration Date:

Jul 22, 2021

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

Manufacturer:

SolGent Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Jul 13, 2021

Exhaled-gas oesophageal intubation detector, adult

Manufacturer:

Westmed Inc.

Type:

General Medical Device

Registration Date:

Jun 29, 2021

Nasal oxygen cannula, carbon-dioxide-sampling

Manufacturer:

Westmed Inc.

Type:

General Medical Device

Registration Date:

Jun 29, 2021

Heated respiratory humidifier

Manufacturer:

Westmed Inc.

Type:

General Medical Device

Registration Date:

Jun 29, 2021

Blood gas syringe/needle, lithium heparin

Manufacturer:

Westmed Inc.

Type:

General Medical Device

Registration Date:

Jun 29, 2021

Exhaled-gas oesophageal intubation detector, paediatric

Manufacturer:

Westmed Inc.

Type:

General Medical Device

Registration Date:

Jun 29, 2021

Rebreathing oxygen face mask

Manufacturer:

Westmed Inc.

Type:

General Medical Device

Registration Date:

Jun 29, 2021

Ventilator breathing circuit, single-use

Manufacturer:

Westmed Inc.

Type:

General Medical Device

Registration Date:

Jun 29, 2021

Nasal oxygen cannula, basic

Manufacturer:

Westmed Inc.

Type:

General Medical Device

Registration Date:

Jun 29, 2021

Microbial medical gas filter, single-use

Manufacturer:

Westmed Inc.

Type:

General Medical Device

Registration Date:

Jun 29, 2021

Medical/surgical interventional tube/cable securement strap

Manufacturer:

Westmed Inc.

Type:

General Medical Device

Registration Date:

Jun 29, 2021

Non-heated respiratory humidifier

Manufacturer:

Westmed Inc.

Type:

General Medical Device

Registration Date:

Jun 29, 2021

Dental handpiece maintenance unit

Manufacturer:

J. MORITA MFG. CORP.

Type:

General Medical Device

Registration Date:

Jun 29, 2021

Surgical instrument maintenance lubricant

Manufacturer:

J. MORITA MFG. CORP.

Type:

General Medical Device

Registration Date:

Jun 29, 2021

Colour discrimination eye chart

Manufacturer:

Konan Medical USA, Inc.

Type:

General Medical Device

Registration Date:

Jun 29, 2021

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

Manufacturer:

Humasis Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Jun 7, 2021

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

Manufacturer:

Humasis Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Jun 7, 2021

Ophthalmic fundus camera

Manufacturer:

Forus Health Pvt. Ltd.

Type:

General Medical Device

Registration Date:

May 31, 2021

Radiology DICOM image processing application software

Manufacturer:

Hanalytics Pte Ltd

Type:

General Medical Device

Registration Date:

May 27, 2021

Eye anterior segment analyser

Manufacturer:

Konan Medical, Inc.

Type:

General Medical Device

Registration Date:

May 27, 2021

Insulin infusion cannula introducer

Manufacturer:

SOOIL Development Co., Ltd.

Type:

General Medical Device

Registration Date:

May 27, 2021

Cough ambulatory recording system

Manufacturer:

ResApp Health Limited

Type:

General Medical Device

Registration Date:

May 20, 2021

Respiratory sound analysis software, professional-only

Manufacturer:

ResApp Health Limited

Type:

General Medical Device

Registration Date:

May 20, 2021

Sleep disorder interpretive software, patient-use

Manufacturer:

ResApp Health Limited

Type:

General Medical Device

Registration Date:

May 20, 2021

Thermal cycler nucleic acid amplification analyser IVD, point-of-care

Manufacturer:

SD Biosensor, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

May 11, 2021

Nucleic acid extraction/isolation kit IVD

Manufacturer:

KH Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

May 7, 2021

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

Manufacturer:

KH Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

May 7, 2021

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

Manufacturer:

KH Medical Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

May 7, 2021

Anti-Jk^a red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-Rh(D) red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-S [MNS004] red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-AB red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-M red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Buffered sample diluent IVD, automated/semi-automated system

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-H red blood cell grouping IVD, lectin

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-P1 red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-C [RH004] red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-E [RH003] red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-E [RH005] red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-Fy^b red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-k (KEL002) red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Bromelin immunohaematology reagent IVD

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Multiple immunohaematology test IVD, control

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-A red blood cell subtype differentiation reagent IVD

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-H red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-N red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-Wr^a red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Blood group/antibody screening analyser IVD

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-A red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-AB red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-A1 red blood cell grouping IVD, lectin

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Buffered isotonic saline reagent IVD

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-C^w red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-C [RH002] red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-Jk^b red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-K (KEL001) red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-B red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Multiple immunohaematology test IVD, control

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-S [MNS003] red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-CDE red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Anti-Fy^a red blood cell grouping IVD, antibody

Manufacturer:

IMMUCOR Medizinische Diagnostik GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 26, 2021

Scalp clip applier, reusable

Manufacturer:

ACRA-CUT, Inc.

Type:

General Medical Device

Registration Date:

Jan 5, 2021

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

Last updated: December 2025