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Obelis UK Ltd

Authorized Representative in the United Kingdom

Sandford Gate, East Point Business Park

Oxford , England, United Kingdom

Postcode: OX4 6LB

Relationship Type: UK Responsible Person
1072 Products Represented
153 Manufacturers
Total Products
1072
Manufacturers
153
Device Types
4
Generic Names
761
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (1072)
Complete portfolio registered with MHRA

Total cortisol IVD, reagent

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

N/A

Prothrombin time (PT) IVD, reagent

Manufacturer:

Universal Biosensors Pty Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

N/A

Suturing needle holder, reusable

Manufacturer:

EMI Factory CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant analog

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation depth/angle gauge, reusable

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation drilling template retention pin

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Amyloid B component IVD, reagent

Manufacturer:

C2N Diagnostics, LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Intraoral camera

Manufacturer:

Dentall Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Uterine tenaculum

Manufacturer:

ASPIVIX SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Troponin I IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total triiodothyronine (TT3) IVD, kit, fluorescent immunoassay

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin I IVD, kit, fluorescent immunoassay

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin T IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amphetamine-specific IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 15-3 (CA15-3) IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clostridium difficile antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fentanyl IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ketamine/ketamine metabolite IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Legionella pneumophila antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methadone IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy vitamin D IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phencyclidine (PCP) IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tricyclic antidepressant IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

EMI Factory CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Guayule-latex examination/treatment glove, non-powdered

Manufacturer:

Eco Medi Glove SDN. BHD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological PACS software

Manufacturer:

INFINITT Healthcare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Earplugs, single-use

Manufacturer:

Innovere Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lice comb, manual

Manufacturer:

SI&D (Aust) Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant abutment impression cap

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental osteotome

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental prosthesis/implant abutment screw

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental torque wrench

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixture/appliance dental drill bit, reusable

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, one-piece

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Air-conduction hearing aid, behind-the-ear

Manufacturer:

audifon GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Air-conduction hearing aid, canal

Manufacturer:

audifon GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Air-conduction hearing aid, receiver-in-canal

Manufacturer:

audifon GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Burn gel

Manufacturer:

Aurena Laboratories AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-purpose therapeutic saline solution

Manufacturer:

Aurena Laboratories AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone nail end-cap

Manufacturer:

Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Femur nail

Manufacturer:

Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Humerus nail

Manufacturer:

Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyester suture, bioabsorbable, multifilament, non-antimicrobial

Manufacturer:

Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyolefin/fluoropolymer suture, monofilament

Manufacturer:

Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tibia nail

Manufacturer:

Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cosmetic micro-needling electronic handpiece cartridge, professional

Manufacturer:

DERMICA LABORATOIRES EUROPE, S.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cosmetic micro-needling electronic handpiece, professional

Manufacturer:

DERMICA LABORATOIRES EUROPE, S.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemodialysis blood tubing set, single-use

Manufacturer:

FARMASOL TIBBİ ÜRÜNLER SAN. VE TİC. A.Ş.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemodialysis concentrate

Manufacturer:

FARMASOL TIBBİ ÜRÜNLER SAN. VE TİC. A.Ş.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological PACS software

Manufacturer:

Focal Heathcare Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radio-frequency skin surface treatment system

Manufacturer:

Pollogen Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haematological concentrate system preparation kit, platelet concentration

Manufacturer:

PROMOITALIA GROUP S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dentine bonding agent/set

Manufacturer:

Prevest DenPro Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Zinc oxide eugenol dental cement

Manufacturer:

Prevest DenPro Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Zinc polycarboxylate dental cement

Manufacturer:

Prevest DenPro Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental bone matrix implant, animal-derived

Manufacturer:

Purgo Biologics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Soft-tissue biopsy procedure kit, non-medicated

Manufacturer:

RF Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oxygen/air breathing gas mixer, hospital

Manufacturer:

Sechrist Industries, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Noninvasive blood pressure physical simulator

Manufacturer:

SELVAS Healthcare, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Full-body CT system

Manufacturer:

Shanghai United Imaging Healthcare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

PET/MRI system

Manufacturer:

Shanghai United Imaging Healthcare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stationary basic diagnostic x-ray system, digital

Manufacturer:

Shanghai United Imaging Healthcare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stationary mammographic x-ray system, digital

Manufacturer:

Shanghai United Imaging Healthcare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyester suture, non-bioabsorbable, multifilament

Manufacturer:

Arcuro Medical Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Magnetic neural stimulation system

Manufacturer:

BrainsWay Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal duodenal stent

Manufacturer:

SEWOON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal oesophageal stent

Manufacturer:

SEWOON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Faecal specimen collection kit IVD, home-use

Manufacturer:

Creative Biosciences (Guangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Creative Biosciences (Guangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Embolization particle, non-bioabsorbable

Manufacturer:

NEXTBIOMEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Embolization particle, non-bioabsorbable

Manufacturer:

NEXTBIOMEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Needleless medication/vaccine injector, mechanical

Manufacturer:

NEXTBIOMEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

TAN SIN LIAN INDUSTRIES SDN. BHD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

TAN SIN LIAN INDUSTRIES SDN. BHD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive disk, reusable

Manufacturer:

TDV DENTAL LTDA.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive disk, reusable

Manufacturer:

TDV DENTAL LTDA.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive disk, reusable

Manufacturer:

TDV DENTAL LTDA.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental mandrel

Manufacturer:

TDV DENTAL LTDA.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rubber dam, non-latex

Manufacturer:

TDV DENTAL LTDA.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Colpotomy tube

Manufacturer:

The O R Company Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument warmer, electric

Manufacturer:

The O R Company Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument warmer, electric

Manufacturer:

The O R Company Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument/endoscope cleaning utensil, single-use

Manufacturer:

The O R Company Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wire/ligature passer, single-use

Manufacturer:

The O R Company Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant holding endpiece

Manufacturer:

Toplan Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

Toplan Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental torque wrench

Manufacturer:

Toplan Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Manufacturer:

Toplan Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Analytical scalp electrode, single-use

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood pressure cuff, reusable

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dressing-fixation skin adhesive tape, non-silicone

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrode/transducer strap, reusable

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye mask

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Low-pressure tubing connector, reusable

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Respiratory oxygen sensor

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tocodynamometer probe

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

ENT illuminating foreign body extraction set

Manufacturer:

Bionix, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

ENT instrument magnifying lens

Manufacturer:

Bionix, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Breast pump, manual

Manufacturer:

Ves Vacuum International Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Incontinence penis clamp, reusable

Manufacturer:

Ves Vacuum International Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pelvic floor internal manual massager

Manufacturer:

Ves Vacuum International Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vaginal dilator

Manufacturer:

Ves Vacuum International Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, resin

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental casting wax

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental porcelain/ceramic restoration kit

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental prosthesis veneer resin

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Resin artificial teeth

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Resin artificial teeth

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Resin artificial teeth

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Inflammatory skin/nerve/joint disorder dressing

Manufacturer:

General Topics Srl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic filling/sealing material

Manufacturer:

Sure Dent Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gingival retraction cord, non-medicated

Manufacturer:

Sure Dent Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held telescope

Manufacturer:

Samsara Vision Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Positive pressure airway secretion-clearing device

Manufacturer:

Kan-Breathe Australia

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

KL-KEPONG RUBBER PRODUCTS SDN BHD

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Finger-stall

Manufacturer:

Riverstone Resources Sdn.Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Riverstone Resources Sdn.Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Aerosol face mask, rebreathing, single-use

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic intravenous administration set, noninvasive

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound/centesis drainage receptacle

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal oxygen cannula, basic

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Negative-pressure intravenous line needleless valve-connector

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-wearable adult urine collection bag, closed-ended

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-wearable adult urine collection bag, closed-ended

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oxygen administration tubing

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Single-administration urethral drainage catheter

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

KOON SENG SDN BHD

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Low-air-loss bed

Manufacturer:

Levabo ApS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General specimen collection kit IVD, clinical

Manufacturer:

Dynamic Code AB

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Infertility genotyping IVD, probe

Manufacturer:

Applied Spectral Imaging Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

Applied Spectral Imaging Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Handgrip disability-assistive walker, non-powered, foldable

Manufacturer:

Ralon Medical Equipment Co.,Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Walking chair, foldable

Manufacturer:

Ralon Medical Equipment Co.,Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ferritin IVD, kit, fluorescent immunoassay

Manufacturer:

Lansion Biotechnology Co.,Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Lansion Biotechnology Co.,Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple autoimmune disease-associated antibody screening IVD, kit, fluorescent immunoassay

Manufacturer:

Lansion Biotechnology Co.,Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple stroke (cerebral vascular accident) marker IVD, kit, fluorescent immunoassay

Manufacturer:

Lansion Biotechnology Co.,Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Lansion Biotechnology Co.,Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid sequencing reagent kit IVD

Manufacturer:

OncoDNA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Activated partial thromboplastin time (APTT) IVD, control

Manufacturer:

Micropoint Biotechnologies Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Mullerian hormone (AMH) IVD, control

Manufacturer:

Micropoint Biotechnologies Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Micropoint Biotechnologies Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation analyser IVD, point-of-care, line-powered

Manufacturer:

Micropoint Biotechnologies Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Decalcifying solution IVD

Manufacturer:

Micropoint Biotechnologies Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, kit, fluorescent immunoassay

Manufacturer:

Micropoint Biotechnologies Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin T/Troponin I IVD, control

Manufacturer:

Micropoint Biotechnologies Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cell morphology analyser IVD, automated/semi-automated

Manufacturer:

Scopio Labs Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cell morphology analyser IVD, automated/semi-automated

Manufacturer:

Scopio Labs Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Physical therapy table, line-powered

Manufacturer:

Reactive Robotics GmbH

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Bed extension

Manufacturer:

Human Care HC AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bed head/footboard

Manufacturer:

Human Care HC AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical return electrode, single-use

Manufacturer:

Gynesonics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Invasive medical device leak tester, mechanical

Manufacturer:

Gynesonics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Invasive medical device leak tester, mechanical

Manufacturer:

Gynesonics Inc.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Sterilization packaging, single-use

Manufacturer:

Gynesonics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sterilization packaging, single-use

Manufacturer:

Gynesonics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasound-guided intrauterine radio-frequency ablation system handpiece/electrode

Manufacturer:

Gynesonics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasound-guided intrauterine radio-frequency ablation system intrauterine ultrasound transducer, reusable

Manufacturer:

Gynesonics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anti-Mullerian hormone (AMH) IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ferritin IVD, kit, fluorescent immunoassay

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Follicle stimulating hormone (FSH) IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free cortisol IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interferon gamma release IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interleukin-6 (IL-6) IVD, reagent

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Luteinizing hormone (LH) IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cell-mediated host immune response marker IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, reagent

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple respiratory virus antigen IVD, kit, fluorescent immunoassay

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Norovirus antigen IVD, reagent

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Progesterone IVD, reagent

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prolactin IVD, kit, fluorescent immunoassay

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rotavirus antigen IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Suppression of tumorigenicity 2 (ST2) IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Suppression of tumorigenicity 2 (ST2) IVD, kit, fluorescent immunoassay

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroid stimulating hormone (TSH) IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

TNF-alpha inhibitor antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total human chorionic gonadotropin IVD, kit, fluorescent immunoassay

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total testosterone IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total testosterone IVD, reagent

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 2 (HSV2) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clinical specimen extraction buffer IVD

Manufacturer:

Creative Biosciences (Guangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inflammatory skin/nerve/joint disorder dressing

Manufacturer:

General Topics Srl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Superficial skin exfoliant, professional

Manufacturer:

General Topics Srl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation depth/angle gauge, single-use

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation drilling template guide-sleeve

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation drilling template guide-sleeve

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental osteotome

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Chisel/osteotome blade handle

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Collagen dental regeneration membrane

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental guided surgery reference plate

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental guided surgery reference plate

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental guided surgery reference plate

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant abutment trial

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant holding endpiece

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure reamer

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, reusable

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixture/appliance dental drill bit, reusable

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held intraoral dental x-ray system, digital

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraoral camera

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mouth gag cover

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Paranasal sinus trephine

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stationary panoramic/tomographic dental x-ray system, digital

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, single-use, non-sterile

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Syringe dispensing gun, reusable

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bar dental precision attachment

Manufacturer:

Panthera Dental Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental occlusal splint, custom-made

Manufacturer:

Panthera Dental Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Panthera Dental Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BODY PRODUCTS RELAX Pharma und Kosmetik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vinyl examination/treatment glove, non-powdered

Manufacturer:

BODY PRODUCTS RELAX Pharma und Kosmetik GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bordetella pertussis nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, kit, chemiluminescent immunoassay

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen container IVD, additive/medium

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

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:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 2 (HSV2) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Atomizer, non-ventilatory

Manufacturer:

Jiangsu Yuyue Medical Equipment & Supply Co. Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbide dental bur, reusable

Manufacturer:

MANI, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic filling material carrier

Manufacturer:

MANI, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual endodontic file/rasp, reusable

Manufacturer:

MANI, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic knife, single-use

Manufacturer:

MANI, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyester suture, non-bioabsorbable, multifilament

Manufacturer:

MANI, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyolefin/fluoropolymer suture, monofilament

Manufacturer:

MANI, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasonic dental scaling/debridement system handpiece tip, endodontic

Manufacturer:

MANI, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex examination/treatment glove, powdered

Manufacturer:

Maxwell Glove Manufacturing Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraocular telescope

Manufacturer:

Samsara Vision Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye lubricant

Manufacturer:

Sentiss Pharma Private Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Adhesive bandage

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cotton wool ball

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose bowl, single-use

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemodialysis system dialyser holder

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medicine cup, single-use

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient surgical drape, single-use

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Shoe cover

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical cap, single-use

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical depth gauge, single-use

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical scrub brush, single-use

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound dressing kit, medicated

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Woven gauze roll/sheet

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic electrode, reusable

Manufacturer:

Shenzhen Launch Electrical Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic lead set, reusable

Manufacturer:

Shenzhen Launch Electrical Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose patient temperature probe, reusable

Manufacturer:

Shenzhen Launch Electrical Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bite registration rim wax, plate

Manufacturer:

Dr. Jean Bausch GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental articulation paper

Manufacturer:

Dr. Jean Bausch GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental articulation paper forceps

Manufacturer:

Dr. Jean Bausch GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

KL-KEPONG RUBBER PRODUCTS SDN BHD

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Riverstone Resources Sdn.Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental suction system cannula, single-use

Manufacturer:

RNDent - IP Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ampule opener

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic endotracheal tube, single-use

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General specimen collection kit

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General specimen collection kit

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral intravenous cannula

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suction system catheter, general-purpose

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical microscope fluorescent angiography system

Manufacturer:

Mitaka Kohki Co LTD

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic diagnostic x-ray system application software

Manufacturer:

DRGEM Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile basic diagnostic x-ray system, digital

Manufacturer:

DRGEM Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Noninvasive vascular ultrasound system, line-powered

Manufacturer:

em-tec GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

Applied Spectral Imaging Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid hybridization detection IVD, reagent

Manufacturer:

Applied Spectral Imaging Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Handgrip disability-assistive walker, non-powered, foldable

Manufacturer:

Ralon Medical Equipment Co.,Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic instrument table, line-powered

Manufacturer:

CX Engineering sp. z o.o.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, resin

Manufacturer:

YAMAHACHI DENTAL MFG., CO.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, resin

Manufacturer:

YAMAHACHI DENTAL MFG., CO.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental casting wax

Manufacturer:

YAMAHACHI DENTAL MFG., CO.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental casting wax

Manufacturer:

YAMAHACHI DENTAL MFG., CO.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Joint prosthesis implantation kit, reusable

Manufacturer:

Aptis Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Joint prosthesis implantation kit, reusable

Manufacturer:

Aptis Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pelvic floor muscle exerciser

Manufacturer:

Ves Vacuum International Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Penile ring

Manufacturer:

Ves Vacuum International Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Visual acuity light box

Manufacturer:

View-M Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Elbow immobilizer

Manufacturer:

Vincent Rehab Devices Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, resin

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental casting wax

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental prosthesis veneer resin

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental prosthesis veneer resin

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental unfilled resin sealant/coating

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Resin artificial teeth

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Resin artificial teeth

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Resin artificial teeth

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Temporary dental crown/bridge

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lice removal/prevention kit

Manufacturer:

SI&D (Aust) Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use

Manufacturer:

NEXTBIOMEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Needleless medication/vaccine injector, mechanical

Manufacturer:

NEXTBIOMEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-organic haemostatic agent

Manufacturer:

NEXTBIOMEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-organic haemostatic agent

Manufacturer:

NEXTBIOMEDICAL CO., LTD.

Type:

System or Procedure Pack

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

Gynesonics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical return electrode, single-use

Manufacturer:

Gynesonics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical return electrode, single-use

Manufacturer:

Gynesonics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-submersible device disinfection chamber

Manufacturer:

Gynesonics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasound-guided intrauterine radio-frequency ablation system

Manufacturer:

Gynesonics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasound-guided intrauterine radio-frequency ablation system handpiece/electrode

Manufacturer:

Gynesonics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasound-guided intrauterine radio-frequency ablation system handpiece/electrode

Manufacturer:

Gynesonics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasound-guided intrauterine radio-frequency ablation system intrauterine ultrasound transducer, single-use

Manufacturer:

Gynesonics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Superficial skin exfoliant, professional

Manufacturer:

General Topics Srl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone lever/elevator, reusable

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone lever/elevator, reusable

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone tap, reusable

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Chisel/osteotome blade handle

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental bone matrix implant, animal-derived

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental bone matrix implant, synthetic

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental delivery system

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental elevator, sinus lift

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant abutment trial

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant holding endpiece

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation depth/angle gauge, reusable

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental soft-tissue coring punch, reusable

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental surgical scissors

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental torque wrench

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual bone mill

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual non-rotary dental instrument handle

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, one-piece

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Silicone dental impression material

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument protective cap

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex examination/treatment glove, powdered

Manufacturer:

TAN SIN LIAN INDUSTRIES SDN. BHD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive disk, reusable

Manufacturer:

TDV DENTAL LTDA.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive strip, single-use

Manufacturer:

TDV DENTAL LTDA.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental matrix band retainer

Manufacturer:

TDV DENTAL LTDA.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Interproximal reduction kit

Manufacturer:

TDV DENTAL LTDA.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument warmer, electric

Manufacturer:

TEN COMFORT CORPORATION

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Colpotomy tube

Manufacturer:

The O R Company Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endoscope antifog solution

Manufacturer:

The O R Company Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Uterine manipulator, single-use

Manufacturer:

The O R Company Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Toplan Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation depth/angle gauge, reusable

Manufacturer:

Toplan Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental prosthesis removal instrument

Manufacturer:

Toplan Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixture/appliance dental drill bit, reusable

Manufacturer:

Toplan Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, two-piece

Manufacturer:

Toplan Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

Toplan Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Toplan Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical torque wrench adaptor

Manufacturer:

Toplan Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stationary intraoral dental x-ray system, digital

Manufacturer:

GENORAY Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stationary panoramic dental x-ray system, digital

Manufacturer:

GENORAY Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stationary panoramic/tomographic dental x-ray system, digital

Manufacturer:

GENORAY Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbide dental bur, single-use

Manufacturer:

Hasharon Dental Center Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive disk, reusable

Manufacturer:

Hasharon Dental Center Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diamond dental bur, reusable

Manufacturer:

Hasharon Dental Center Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diamond dental bur, single-use

Manufacturer:

Hasharon Dental Center Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oxygen/air breathing gas mixer, hospital

Manufacturer:

Inovytec Medical Solutions Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oxygen/air breathing gas mixer, hospital

Manufacturer:

Inovytec Medical Solutions Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Sanway Gene Tech. Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay

Manufacturer:

Boditech Med 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:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatine kinase myocardial isoenzyme (CKMB) IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cyclic citrullinated peptide antibody (anti-CCP) IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, kit, fluorescent immunoassay

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ferritin IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ferritin IVD, kit, fluorescent immunoassay

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fluorescent immunoassay analyser IVD, point-of-care

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free thyroxine (FT4) IVD, kit, fluorescent immunoassay

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human chorionic gonadotropin beta-subunit (beta-HCG)/follicle stimulating hormone (FSH) IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human chorionic gonadotropin beta-subunit (beta-HCG)/follicle stimulating hormone (FSH) IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interferon gamma release IVD, kit, fluorescent immunoassay

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, kit, fluorescent immunoassay

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoglobin IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, kit, fluorescent immunoassay

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rotavirus antigen IVD, reagent

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sialylated carbohydrate antigen KL-6 IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sialylated carbohydrate antigen KL-6 IVD, reagent

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cortisol IVD, reagent

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total thyroxine (TT4) IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin I IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, reagent

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Benzodiazepine group IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cotinine IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple alcohol IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry protein IVD, reagent

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple tissue-associated protein/tumour marker IVD, reagent

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Acro Biotech, 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:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin T IVD, reagent

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech 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:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Molecular grade lysis reagent IVD

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple enterovirus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech 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:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Specimen stabilization reagent IVD

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Streptococcus pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alternating-pressure chair cushion, reusable

Manufacturer:

Carilex Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

ENFit/ENFit linear connector

Manufacturer:

Cedic srl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

ENFit/non-ISO80369-standardized linear connector

Manufacturer:

Cedic srl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Enteral feeding noninvasive-component set

Manufacturer:

Cedic srl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Enteral feeding noninvasive-component set

Manufacturer:

Cedic srl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasoenteral tube

Manufacturer:

Cedic srl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment handle cover, single-use

Manufacturer:

Pharma - Sept Medical Products Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient surgical drape, single-use

Manufacturer:

Pharma - Sept Medical Products Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sharp surgical instrument counting tray/pad, single-use

Manufacturer:

Pharma - Sept Medical Products Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin marking pen, single-use

Manufacturer:

Pharma - Sept Medical Products Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Pharma - Sept Medical Products Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

Gynesonics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Specimen container mailer, non-insulated

Manufacturer:

Gynesonics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Specimen container mailer, non-insulated

Manufacturer:

Gynesonics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasound-guided intrauterine radio-frequency ablation system

Manufacturer:

Gynesonics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasound-guided intrauterine radio-frequency ablation system

Manufacturer:

Gynesonics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ultrasound-guided intrauterine radio-frequency ablation system intrauterine ultrasound transducer, reusable

Manufacturer:

Gynesonics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone graft funnel

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental drill bit extension

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental guided surgery reference pin

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Extra-gynaecological surgical mesh, metal

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose bowl, reusable

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual non-rotary dental instrument handle

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgery tissue debris collector, reusable

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Periodontal curette

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, two-piece

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin-port tissue expander

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical apron, single-use

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument protective cap

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Osstem Implant Co., Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Activated partial thromboplastin time (APTT) IVD, kit, rapid clotting, clinical

Manufacturer:

Micropoint Biotechnologies Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Micropoint Biotechnologies Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fibrinogen assay (factor I) IVD, kit, clotting

Manufacturer:

Micropoint Biotechnologies Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, control

Manufacturer:

Micropoint Biotechnologies Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prothrombin time (PT) IVD, control

Manufacturer:

Micropoint Biotechnologies Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prothrombin time (PT) IVD, kit, rapid clotting, clinical

Manufacturer:

Micropoint Biotechnologies Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin I IVD, kit, fluorescent immunoassay

Manufacturer:

Micropoint Biotechnologies Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen collection kit IVD, home-use

Manufacturer:

Prenetics Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sejoy Biomedical Co.,Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Basic electric hospital bed

Manufacturer:

Human Care HC AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Breathing circuit tube holder

Manufacturer:

Human Care HC AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous pole

Manufacturer:

Human Care HC AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluorescent immunoassay analyser IVD, laboratory, semi-automated

Manufacturer:

Lansion Biotechnology Co.,Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, kit, fluorescent immunoassay

Manufacturer:

Lansion Biotechnology Co.,Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple female fertility marker IVD, kit, rapid ICT, clinical

Manufacturer:

Lansion Biotechnology Co.,Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple gastrointestinal disease marker IVD, kit, fluorescent immunoassay, rapid

Manufacturer:

Lansion Biotechnology Co.,Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple thyroid antibody IVD, kit, fluorescent immunoassay

Manufacturer:

Lansion Biotechnology Co.,Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Surgical/medical procedure irrigation fluid

Manufacturer:

Sentiss Pharma Private Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ophthalmic cannulation set, single-use

Manufacturer:

MANI, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rotary/reciprocating endodontic file/rasp, reusable

Manufacturer:

MANI, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Silk suture

Manufacturer:

MANI, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Steel dental bur, reusable

Manufacturer:

MANI, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Maxwell Glove Manufacturing Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Denture cleanser

Manufacturer:

Mid-Continental Dental Supply Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthodontic appliance cleanser

Manufacturer:

Mid-Continental Dental Supply Co. Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

WRP Asia Pacific Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

WRP Asia Pacific Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hevea-latex surgical glove, powdered

Manufacturer:

WRP Asia Pacific Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

WRP Asia Pacific Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

WRP Asia Pacific Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polychloroprene surgical glove, non-powdered

Manufacturer:

WRP Asia Pacific Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile general-purpose fluoroscopic x-ray system, digital

Manufacturer:

GENORAY Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stationary mammographic x-ray system, digital

Manufacturer:

GENORAY Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbide dental bur, reusable

Manufacturer:

Hasharon Dental Center Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Physical therapy transcutaneous neuromuscular electrical stimulation system

Manufacturer:

Johari Digital Healthcare Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbide dental bur, single-use

Manufacturer:

MDT Micro Diamond Technologies Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive disk, reusable

Manufacturer:

MDT Micro Diamond Technologies Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diamond dental bur, single-use

Manufacturer:

MDT Micro Diamond Technologies Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Red-light phototherapy unit, professional

Manufacturer:

Meditech International Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, calibrator

Manufacturer:

OSANG Healthcare Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Transcutaneous electrical stimulation electrode, reusable

Manufacturer:

BioWave Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrosurgical handpiece/electrode holder, single-use

Manufacturer:

The O R Company Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument warmer, exothermic chemical

Manufacturer:

The O R Company Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin marking pen, single-use

Manufacturer:

The O R Company Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suction system filter, plume particulate

Manufacturer:

The O R Company Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Uterine manipulator, single-use

Manufacturer:

The O R Company Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wire/ligature passer, reusable

Manufacturer:

The O R Company Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental drill bit extension

Manufacturer:

Toplan Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant internal thread shaping tool

Manufacturer:

Toplan Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

Toplan Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Manufacturer:

Toplan Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw-extraction orthopaedic reamer, reusable

Manufacturer:

Toplan Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Toplan Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic lead set, single-use

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Foetal Doppler system probe

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose patient temperature probe, single-use

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Invasive-pressure external transducer, single-use

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pulse oximeter probe, single-use

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

ENT foreign body extraction forceps

Manufacturer:

Bionix, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose bowl, reusable

Manufacturer:

Bionix, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ear canal irrigation kit, reusable

Manufacturer:

Bionix, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ear canal irrigation tip

Manufacturer:

Bionix, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Injection site desensitizer, tactile, reusable

Manufacturer:

Bionix, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal speculum, single-use

Manufacturer:

Bionix, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Phototherapy infant blanket

Manufacturer:

Bionix, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nipple former

Manufacturer:

Ves Vacuum International Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Penile vacuum device

Manufacturer:

Ves Vacuum International Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Heel protector

Manufacturer:

Vincent Rehab Devices Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Knee immobilizer

Manufacturer:

Vincent Rehab Devices Company Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Prescription spectacle lens, non-customized

Manufacturer:

Vision Rx Lab Private Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental appliance fabrication material, ceramic

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental porcelain/ceramic restoration kit

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental unfilled resin sealant/coating

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Resin artificial teeth

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Temporary dental crown/bridge

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Temporary dental crown/bridge

Manufacturer:

VITA Zahnfabrik H. Rauter GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiological PACS software

Manufacturer:

INFINITT Healthcare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Freestanding patient positioner, reusable

Manufacturer:

Innovere Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental tooth-cleaning solution

Manufacturer:

Sure Dent Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neisseria gonorrhoeae nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid sample preparation instrument IVD, semi-automated

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Specimen stabilization reagent IVD

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin I IVD, kit, chemiluminescent immunoassay

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ureaplasma urealyticum nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ureaplasma urealyticum nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Orthodontic retainer

Manufacturer:

Smylio Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Alternating-pressure bed mattress overlay system

Manufacturer:

Carilex Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Negative-pressure wound therapy system foam dressing, non-antimicrobial

Manufacturer:

Carilex Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

ENFit/non-ISO80369-standardized linear connector

Manufacturer:

Cedic srl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraoperative ultrasound imaging transducer cover

Manufacturer:

Pharma - Sept Medical Products Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Platelet aggregation analyser IVD

Manufacturer:

Chrono-log Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Platelet aggregation study IVD, reagent

Manufacturer:

Chrono-log Corporation

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Electrocardiograph, professional, single-channel

Manufacturer:

AliveCor Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Air-conduction tinnitus masker, in-the-ear

Manufacturer:

audifon GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Air-conduction tinnitus masker, out-of-ear

Manufacturer:

audifon GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-purpose therapeutic saline solution

Manufacturer:

Aurena Laboratories AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

Manufacturer:

Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nylon suture, non-bioabsorbable, monofilament

Manufacturer:

Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nylon suture, non-bioabsorbable, multifilament

Manufacturer:

Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone nut

Manufacturer:

Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone screw, non-bioabsorbable, sterile

Manufacturer:

Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone washer, sterile

Manufacturer:

Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

Manufacturer:

Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound hydrogel dressing, non-antimicrobial

Manufacturer:

Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Musculoskeletal/physical therapy laser, home-use

Manufacturer:

Biocare Enterprise Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Parallel-plate haemodialysis dialyser, disposable-insert

Manufacturer:

FARMASOL TIBBİ ÜRÜNLER SAN. VE TİC. A.Ş.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radio-frequency skin contouring system applicator tip

Manufacturer:

Pollogen Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermal tissue reconstructive material, animal-derived

Manufacturer:

PROMOITALIA GROUP S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dermal tissue reconstructive material, microbe-derived

Manufacturer:

PROMOITALIA GROUP S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin kit

Manufacturer:

Prevest DenPro Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dentifrice

Manufacturer:

Prevest DenPro Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fatty acid dental cement

Manufacturer:

Prevest DenPro Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Glass ionomer dental cement

Manufacturer:

Prevest DenPro Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hygroscopic dental cement

Manufacturer:

Prevest DenPro Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Clinical management support software

Manufacturer:

Resilience MD

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Percutaneous radio-frequency ablation system generator

Manufacturer:

RF Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bioelectrical body composition analyser

Manufacturer:

SELVAS Healthcare, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diagnostic x-ray digital imaging system workstation

Manufacturer:

Shanghai United Imaging Healthcare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile basic diagnostic x-ray system, digital

Manufacturer:

Shanghai United Imaging Healthcare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

MRI system application software

Manufacturer:

Shanghai United Imaging Healthcare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

PET/CT system

Manufacturer:

Shanghai United Imaging Healthcare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

PET/CT system

Manufacturer:

Shanghai United Imaging Healthcare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiology DICOM image processing application software

Manufacturer:

Shanghai United Imaging Healthcare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stationary basic diagnostic x-ray system, digital

Manufacturer:

Shanghai United Imaging Healthcare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Female condom, Hevea-latex

Manufacturer:

Cupid Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Micropoint Biotechnologies Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, control

Manufacturer:

Micropoint Biotechnologies Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, kit, fluorescent immunoassay

Manufacturer:

Micropoint Biotechnologies Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fibrinogen assay (factor I) IVD, control

Manufacturer:

Micropoint Biotechnologies Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fluorescent immunoassay analyser IVD, point-of-care, line-powered

Manufacturer:

Micropoint Biotechnologies Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, control

Manufacturer:

Micropoint Biotechnologies Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, kit, fluorescent immunoassay

Manufacturer:

Micropoint Biotechnologies Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cell morphology analyser IVD, automated/semi-automated

Manufacturer:

Scopio Labs Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

Suzhou Molarray Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bioelectrical body composition analyser

Manufacturer:

CHARDER ELECTRONIC CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Chair scale, electronic

Manufacturer:

CHARDER ELECTRONIC CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient-height measure

Manufacturer:

CHARDER ELECTRONIC CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Transport wheelchair, collapsible

Manufacturer:

Circle Specialty Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiology information system application software

Manufacturer:

Implicity

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External defibrillation electrode, adult, single-use

Manufacturer:

Progetti S.r.l

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Physiologic-monitoring defibrillation system

Manufacturer:

Progetti S.r.l

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bedrail

Manufacturer:

Human Care HC AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Frame/rail/pole device holder

Manufacturer:

Human Care HC AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient lifting pole

Manufacturer:

Human Care HC AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiology DICOM image processing application software

Manufacturer:

Aidoc Medical Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fructose/lactose intolerance IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Dynamic Code AB

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urogenital specimen collection kit IVD, home-use

Manufacturer:

Dynamic Code AB

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation analyser IVD, point-of-care, line-powered

Manufacturer:

Entegrion, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer associated serum antigen (CASA) IVD, reagent

Manufacturer:

Lansion Biotechnology Co.,Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Lansion Biotechnology Co.,Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple coagulation factor IVD, kit, clotting

Manufacturer:

Lansion Biotechnology Co.,Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Endotracheal tube introducer, single-use

Manufacturer:

Adroit Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rigid intubation laryngoscope, single-use

Manufacturer:

Adroit Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rotary/reciprocating endodontic file/rasp, single-use

Manufacturer:

Jining Orodeka Medical Equipment Co.,Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbide dental bur, reusable

Manufacturer:

MDT Micro Diamond Technologies Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbide dental bur, reusable

Manufacturer:

MDT Micro Diamond Technologies Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive point, single-use

Manufacturer:

MDT Micro Diamond Technologies Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental polishing cup, single-use

Manufacturer:

MDT Micro Diamond Technologies Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Musculoskeletal/physical therapy laser, home-use

Manufacturer:

Medical Quant Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Red-light phototherapy unit, professional

Manufacturer:

Meditech International Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Glucose IVD, control

Manufacturer:

OSANG Healthcare Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose monitoring system IVD, home-use

Manufacturer:

OSANG Healthcare Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mandible-repositioning sleep-disordered breathing orthosis

Manufacturer:

Panthera Dental Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Posterior-chamber intraocular lens, phakic

Manufacturer:

STAAR Surgical Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Angiographic syringe

Manufacturer:

Beijing Demax Medical Technology Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Angiography kit

Manufacturer:

Beijing Demax Medical Technology Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pressure transducer dome, single-use

Manufacturer:

Beijing Demax Medical Technology Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular catheter introduction set, nonimplantable

Manufacturer:

Beijing Demax Medical Technology Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic filling/sealing material

Manufacturer:

Sure Dent Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gingival retraction cord, medicated

Manufacturer:

Sure Dent Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Synthetic gutta-percha

Manufacturer:

Sure Dent Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, two-piece

Manufacturer:

HIOSSEN, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal colonic stent

Manufacturer:

SEWOON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oesophageal stent reflux-control device

Manufacturer:

SEWOON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal biliary stent, non-bioabsorbable

Manufacturer:

SEWOON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Specimen processing instrument IVD

Manufacturer:

Creative Biosciences (Guangzhou) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Blood pressure cuff, single-use

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrical-only medical device connection cable, reusable

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic electrode, reusable

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic lead set, reusable

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrocardiographic lead set, reusable

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External cuff/pad connection tubing

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye mask

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose patient temperature probe, reusable

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous pressure infusor, manual, reusable

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pulse oximeter

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pulse oximeter probe, reusable

Manufacturer:

Unimed Medical Supplies, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endaural wax extraction curette

Manufacturer:

Bionix, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

ENT instrument light source

Manufacturer:

Bionix, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Enteral feeding tube clearing kit

Manufacturer:

Bionix, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

WRP Asia Pacific Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polychloroprene surgical glove, non-powdered

Manufacturer:

WRP Asia Pacific Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyisoprene surgical glove, non-powdered, non-antimicrobial

Manufacturer:

WRP Asia Pacific Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyisoprene surgical glove, non-powdered, non-antimicrobial

Manufacturer:

WRP Asia Pacific Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Assay development analyte-specific reagent IVD

Manufacturer:

ABDOS Labtech Pvt. LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Centrifuge tube IVD

Manufacturer:

ABDOS Labtech Pvt. LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen container IVD, no additive/medium

Manufacturer:

ABDOS Labtech Pvt. LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Non-evacuated urine specimen container IVD, no additive

Manufacturer:

ABDOS Labtech Pvt. LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

PCR/NAT negative control IVD

Manufacturer:

ABDOS Labtech Pvt. LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pipette tip IVD

Manufacturer:

ABDOS Labtech Pvt. LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

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:

Sansure Biotech 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:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoglobin IVD, kit, chemiluminescent immunoassay

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neisseria gonorrhoeae nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid sample preparation instrument IVD

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Streptococcus pneumoniae nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Orthodontic progressive aligner

Manufacturer:

Smylio Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Alternating-pressure bed mattress overlay system

Manufacturer:

Carilex Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Alternating-pressure chair cushion, reusable

Manufacturer:

Carilex Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Negative-pressure wound therapy system pump, electric

Manufacturer:

Carilex Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

ENFit/Luer linear connector

Manufacturer:

Cedic srl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Enteral feeding noninvasive-component set

Manufacturer:

Cedic srl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Enteral feeding noninvasive-component set

Manufacturer:

Cedic srl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasogastric feeding tube

Manufacturer:

Cedic srl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Instrument management bag

Manufacturer:

Pharma - Sept Medical Products Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical equipment drape, single-use

Manufacturer:

Pharma - Sept Medical Products Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Anti-Mullerian hormone (AMH) IVD, reagent

Manufacturer:

Boditech Med 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:

Boditech Med 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:

Boditech Med 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:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Evacuated blood collection tube IVD, anticoagulant

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Follicle stimulating hormone (FSH) IVD, reagent

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free thyroxine (FT4) IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, reagent

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Heating block IVD

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interleukin-6 (IL-6) IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Luteinizing hormone (LH) IVD, reagent

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microalbumin IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microalbumin IVD, reagent

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, reagent

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple gastrointestinal virus antigen IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple human hormone IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple tissue-associated protein/tumour marker IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-therapy therapeutic drug monitoring IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-therapy therapeutic drug monitoring IVD, reagent

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoglobin IVD, kit, fluorescent immunoassay

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Norovirus antigen IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Progesterone IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prolactin IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cortisol IVD, reagent

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total human chorionic gonadotropin (HCG) IVD, kit, fluorescent immunoassay

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total immunoglobulin E (IgE total) IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total prostate specific antigen (tPSA) IVD, kit, fluorescent immunoassay

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total thyroxine (TT4) IVD, kit, fluorescent immunoassay

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total triiodothyronine (TT3) IVD, control

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin T IVD, kit, fluorescent immunoassay

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microplate IVD

Manufacturer:

ABDOS Labtech Pvt. LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lactoferrin IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 125 (CA125) IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Candida albicans antigen IVD, reagent

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ethyl glucuronide (EtG) IVD, reagent

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methamphetamine-specific IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neisseria gonorrhoeae antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pregabalin IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Salmonella typhi antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin T IVD, kit, rapid ICT, clinical

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Basic diagnostic x-ray system application software

Manufacturer:

DRGEM Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual-aperture-control diagnostic x-ray system collimator, non-motorized

Manufacturer:

DRGEM Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile basic diagnostic x-ray system, analogue

Manufacturer:

DRGEM Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stationary basic diagnostic x-ray system, digital

Manufacturer:

DRGEM Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

X-ray system tube

Manufacturer:

DRGEM Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone screw, non-bioabsorbable, sterile

Manufacturer:

Aptis Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electrode conductive skin pad, single-use

Manufacturer:

Progetti S.r.l

Type:

General Medical Device

Registration Date:

Nov 26, 2024

External defibrillation electrode, paediatric, single-use

Manufacturer:

Progetti S.r.l

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oesophageal bougie, single-use

Manufacturer:

Adroit Surgical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiology DICOM image processing application software

Manufacturer:

Aidoc Medical Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sexually transmitted infection (STI) testing specimen collection kit IVD, home-use

Manufacturer:

Dynamic Code AB

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ophthalmic instrument table, line-powered

Manufacturer:

CX Engineering sp. z o.o.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bed scale

Manufacturer:

CHARDER ELECTRONIC CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infant scale, electronic

Manufacturer:

CHARDER ELECTRONIC CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stand-on floor scale, electronic

Manufacturer:

CHARDER ELECTRONIC CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wheelchair-accessible platform scale

Manufacturer:

CHARDER ELECTRONIC CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Electric-motor-driven wheelchair, occupant-controlled

Manufacturer:

Jiangsu Yuyue Medical Equipment & Supply Co. Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device air compressor

Manufacturer:

Jiangsu Yuyue Medical Equipment & Supply Co. Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vacuum suction regulator/regulation set, general-purpose

Manufacturer:

Jiangsu Yuyue Medical Equipment & Supply Co. Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Antiseptic swab

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bandage scissors, single-use

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bib/apron, adult, single-use

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dressing-fixation skin adhesive tape, non-silicone

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dressing-fixation skin adhesive tape, non-silicone

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dressing/utility forceps, scissors-like, reusable

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dressing/utility forceps, tweezers-like, single-use

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Exudate-absorbent dressing, non-gel, non-antimicrobial

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Gauze strip, non-antimicrobial

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose bowl, single-use

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose surgical scissors, single-use

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Skin stapler/staple, non-bioabsorbable

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suture removal kit

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suturing needle holder, single-use

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Woven gauze pad, non-sterile

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hyperspectral imaging camera

Manufacturer:

Spectral MD, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Guayule-latex examination/treatment glove, non-powdered

Manufacturer:

Riverstone Resources Sdn.Bhd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood transfusion set, non-exchange

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Closed-wound/centesis drainage receptacle

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

CPAP/BPAP face mask, single-use

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Incentive spirometer

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Indwelling urethral drainage balloon catheter, non-antimicrobial

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous administration tubing extension set

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intravenous line stopcock

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasogastric feeding tube

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-rebreathing oxygen face mask

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Suction/irrigation tubing, single-use

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urine flowmeter, single-use

Manufacturer:

Romsons International (Unit-II)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Basic electric home bed

Manufacturer:

RotoBed ApS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

KOON SENG SDN BHD

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound hydrogel dressing, non-antimicrobial

Manufacturer:

Koru Pharma Co.,Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

KSG MEDICARE SDN BHD

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General-purpose surgical microscope

Manufacturer:

Mitaka Kohki Co LTD

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraocular lens calculation software

Manufacturer:

STAAR Surgical Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Catheter/overtube balloon inflator, single-use

Manufacturer:

Beijing Demax Medical Technology Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rotating pneumatic tourniquet system

Manufacturer:

Beijing Demax Medical Technology Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental base plate

Manufacturer:

YAMAHACHI DENTAL MFG., CO.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Resin artificial teeth

Manufacturer:

YAMAHACHI DENTAL MFG., CO.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Resin artificial teeth

Manufacturer:

YAMAHACHI DENTAL MFG., CO.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

X-ray image interpretive software

Manufacturer:

Lunit Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument assist arm system, manually-adjusted

Manufacturer:

Mitaka Kohki Co LTD

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Moisture/lubrication otic solution

Manufacturer:

Sentiss Pharma Private Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Absorbent underpad, non-antimicrobial, single-use

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cotton wool ball, sterile

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye pad

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Isolation gown, single-use

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-woven gauze pad

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-woven gauze pad, non-sterile

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pressure bandage, non-latex, single-use

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Rescue blanket, reusable

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical scrub brush, single-use

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical/medical face mask, single-use

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tongue depressor, surgical

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound dressing kit, non-medicated

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound-nonadherent dressing, absorbent, non-antimicrobial

Manufacturer:

SHAOXING YIBON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation drilling template guide-sleeve

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental suction system cannula, reusable

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixture/appliance dental drill bit, reusable

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical depth gauge, reusable

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, single-use, non-sterile

Manufacturer:

SIN SISTEMA DE IMPLANTE NACIONAL S/A

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bite registration rim wax, plate

Manufacturer:

Dr. Jean Bausch GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental articulation paste/solution

Manufacturer:

Dr. Jean Bausch GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Interproximal/occlusal dental gauge, single-use

Manufacturer:

Dr. Jean Bausch GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diagnostic x-ray system generator, stationary

Manufacturer:

DRGEM Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stationary basic diagnostic x-ray system, analogue

Manufacturer:

DRGEM Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Eco Medi Glove SDN. BHD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Histology/cytology/microbiology image-analysis interpretive software IVD

Manufacturer:

INFINITT Healthcare Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Radiological PACS software

Manufacturer:

INFINITT Healthcare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical cushion cover

Manufacturer:

Innovere Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient audiovisual communication/entertainment system

Manufacturer:

Innovere Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Secondary battery

Manufacturer:

Innovere Medical Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Vascular scissors

Manufacturer:

EMI Factory CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ankle/foot orthosis

Manufacturer:

EUMEDICA SRL

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diamond dental bur, reusable

Manufacturer:

MANI, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nylon suture, non-bioabsorbable, monofilament

Manufacturer:

MANI, INC.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Maxwell Glove Manufacturing Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiology information system application software

Manufacturer:

Implicity

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Tubular support bandage, non-latex, reusable

Manufacturer:

Incrediwear Holdings, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Manufacturer:

Jiangsu Yuyue Medical Equipment & Supply Co. Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, skin

Manufacturer:

Jiangsu Yuyue Medical Equipment & Supply Co. Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile/portable oxygen concentrator

Manufacturer:

Jiangsu Yuyue Medical Equipment & Supply Co. Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pulse oximeter

Manufacturer:

Jiangsu Yuyue Medical Equipment & Supply Co. Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nipple pad/ring, single-use

Manufacturer:

Southwest Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound management image-analysis software

Manufacturer:

Spectral MD, Inc

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Transcutaneous electrical stimulation electrode, reusable

Manufacturer:

Ampcare, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wrist ulna-head prosthesis

Manufacturer:

Aptis Medical LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Eye patch

Manufacturer:

PIETRASANTA PHARMA S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient sling scale

Manufacturer:

CHARDER ELECTRONIC CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oral mucositis cryotherapy mouthpiece

Manufacturer:

Chemo Mouthpiece LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Intraocular lens-insertion cartridge

Manufacturer:

STAAR Surgical Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual intraocular lens injector, reusable

Manufacturer:

STAAR Surgical Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual intraocular lens injector, single-use

Manufacturer:

STAAR Surgical Company

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Coronary angioplasty balloon catheter, basic

Manufacturer:

Beijing Demax Medical Technology Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemostasis valve

Manufacturer:

Beijing Demax Medical Technology Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Luer/Luer linear connector, single-use

Manufacturer:

Beijing Demax Medical Technology Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stopcock

Manufacturer:

Beijing Demax Medical Technology Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Eco Medi Glove SDN. BHD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Endodontic paper point

Manufacturer:

Sure Dent Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiology DICOM image processing application software

Manufacturer:

Aidoc Medical Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental base plate

Manufacturer:

YAMAHACHI DENTAL MFG., CO.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

WRP Asia Pacific Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

WRP Asia Pacific Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

WRP Asia Pacific Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

WRP Asia Pacific Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrile surgical glove, non-powdered

Manufacturer:

WRP Asia Pacific Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nitrile surgical glove, non-powdered

Manufacturer:

WRP Asia Pacific Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyisoprene surgical glove, non-powdered, non-antimicrobial

Manufacturer:

WRP Asia Pacific Sdn Bhd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Preformed dental crown, permanent

Manufacturer:

YAMAHACHI DENTAL MFG., CO.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Preformed dental crown, permanent

Manufacturer:

YAMAHACHI DENTAL MFG., CO.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Air-conduction hearing aid, in-the-ear

Manufacturer:

audifon GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Audiometric/hearing device configuration kit

Manufacturer:

audifon GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Audiometric/hearing device software

Manufacturer:

audifon GmbH & Co. KG

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Burn gel

Manufacturer:

Aurena Laboratories AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multi-purpose therapeutic saline solution

Manufacturer:

Aurena Laboratories AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nasal irrigation saline solution

Manufacturer:

Aurena Laboratories AB

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Enteral feeding pump

Manufacturer:

Axium MTech SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Antimicrobial wound irrigation solution

Manufacturer:

Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hip internal fixation system

Manufacturer:

Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nylon suture, non-bioabsorbable, multifilament

Manufacturer:

Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic fixation plate, non-bioabsorbable

Manufacturer:

Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyester suture, non-bioabsorbable, multifilament

Manufacturer:

Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Silk suture

Manufacturer:

Bactiguard (South East Asia) Sdn. Bhd. (formerly known as VIGILENZ Medical Devices Sdn. Bhd.)

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood/tissue storage/culture container

Manufacturer:

CLINIPRO, S.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Physical therapy transcutaneous neuromuscular electrical stimulation system

Manufacturer:

BioWave Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system lead

Manufacturer:

BioWave Corporation

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin

Manufacturer:

Prevest DenPro Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Zinc phosphate dental cement

Manufacturer:

Prevest DenPro Limited

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyolefin/fluoropolymer suture, monofilament

Manufacturer:

Purgo Biologics Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Epidural anaesthesia set, non-medicated

Manufacturer:

RF Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

RF Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar

Manufacturer:

RF Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Peripheral vascular electrocautery catheter, single-use

Manufacturer:

RF Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Side-notch biopsy gun handpiece/needle

Manufacturer:

RF Medical Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Full-body CT system

Manufacturer:

Shanghai United Imaging Healthcare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Full-body MRI system, superconducting magnet

Manufacturer:

Shanghai United Imaging Healthcare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile general-purpose fluoroscopic x-ray system, digital

Manufacturer:

Shanghai United Imaging Healthcare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Full-body MRI system, superconducting magnet

Manufacturer:

Shanghai United Imaging Healthcare Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Infant apnoea monitor

Manufacturer:

Hisense Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General oral wound dressing, non-animal-derived

Manufacturer:

Labomar S.p.A. a socio unico

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multiple vital physiological parameter monitoring system, home-use

Manufacturer:

Owlet Baby Care, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal biliary stent

Manufacturer:

SEWOON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bare-metal duodenal stent

Manufacturer:

SEWOON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal colonic stent

Manufacturer:

SEWOON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer-metal tracheal/bronchial stent

Manufacturer:

SEWOON MEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Non-organic haemostatic agent

Manufacturer:

NEXTBIOMEDICAL CO., LTD.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental matrix band, single-use

Manufacturer:

TDV DENTAL LTDA.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dentifrice

Manufacturer:

TDV DENTAL LTDA.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Citric acid haemodialysis system cleaning cartridge

Manufacturer:

FARMASOL TIBBİ ÜRÜNLER SAN. VE TİC. A.Ş.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Haemodialysis needle

Manufacturer:

FARMASOL TIBBİ ÜRÜNLER SAN. VE TİC. A.Ş.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical device disinfection agent

Manufacturer:

FARMASOL TIBBİ ÜRÜNLER SAN. VE TİC. A.Ş.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical simulation system

Manufacturer:

Galgo Medical S.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental digital imaging sensor, intraoral

Manufacturer:

GENORAY Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hand-held intraoral dental x-ray system, digital

Manufacturer:

GENORAY Co., Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive point, reusable

Manufacturer:

Hasharon Dental Center Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Inspiratory/expiratory limb respiratory tubing, single-use

Manufacturer:

Inovytec Medical Solutions Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Transport electric ventilator

Manufacturer:

Inovytec Medical Solutions Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General oral wound dressing, non-animal-derived

Manufacturer:

Labomar S.p.A. a socio unico

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oropharyngeal mucosa protection material

Manufacturer:

Labomar S.p.A. a socio unico

Type:

General Medical Device

Registration Date:

Nov 26, 2024

X-ray image interpretive software

Manufacturer:

Lunit Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carbide dental bur, single-use

Manufacturer:

MDT Micro Diamond Technologies Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive disk, reusable

Manufacturer:

MDT Micro Diamond Technologies Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental abrasive point, reusable

Manufacturer:

MDT Micro Diamond Technologies Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental polishing cup, reusable

Manufacturer:

MDT Micro Diamond Technologies Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diamond dental bur, reusable

Manufacturer:

MDT Micro Diamond Technologies Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diamond dental bur, reusable

Manufacturer:

MDT Micro Diamond Technologies Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Diamond dental bur, single-use

Manufacturer:

MDT Micro Diamond Technologies Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Glucose IVD, reagent

Manufacturer:

OSANG Healthcare Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1C) analyser IVD

Manufacturer:

OSANG Healthcare Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, calibrator

Manufacturer:

OSANG Healthcare Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, reagent

Manufacturer:

OSANG Healthcare Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Evacuated blood collection tube IVD, anticoagulant/separator/density solution

Manufacturer:

ABDOS Labtech Pvt. LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Non-evacuated blood collection tube IVD, no additive

Manufacturer:

ABDOS Labtech Pvt. LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gamma-hydroxybutyrate (GHB) IVD, reagent

Manufacturer:

Acro Biotech, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human metapneumovirus (hMPV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Legionella pneumophila nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Molecular grade lysis reagent IVD

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Sansure Biotech 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:

Sansure Biotech Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bone wax, natural

Manufacturer:

FUTURA SURGICARE PVT LTD

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Cryolipolysis body contouring system

Manufacturer:

PROMOITALIA GROUP S.p.A.

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Metallic suture, monofilament

Manufacturer:

FUTURA SURGICARE PVT LTD

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Skin stapler/staple, non-bioabsorbable

Manufacturer:

FUTURA SURGICARE PVT LTD

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Polyester suture, non-bioabsorbable, multifilament

Manufacturer:

FUTURA SURGICARE PVT LTD

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Polyester suture, bioabsorbable, multifilament, non-antimicrobial

Manufacturer:

FUTURA SURGICARE PVT LTD

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

Manufacturer:

FUTURA SURGICARE PVT LTD

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Nylon suture, non-bioabsorbable, monofilament

Manufacturer:

FUTURA SURGICARE PVT LTD

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Composite-polymer suture

Manufacturer:

FUTURA SURGICARE PVT LTD

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

Manufacturer:

FUTURA SURGICARE PVT LTD

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Polyolefin/fluoropolymer suture, monofilament

Manufacturer:

FUTURA SURGICARE PVT LTD

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Silk suture

Manufacturer:

FUTURA SURGICARE PVT LTD

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Dressing-fixation skin adhesive tape, non-silicone

Manufacturer:

FUTURA SURGICARE PVT LTD

Type:

General Medical Device

Registration Date:

Nov 22, 2024

Dried blood spot collection kit IVD

Manufacturer:

ZRT Laboratory

Type:

In Vitro Diagnostic Device

Registration Date:

Oct 29, 2024

Human genomic analysis interpretive software IVD

Manufacturer:

Ziwig

Type:

In Vitro Diagnostic Device

Registration Date:

Oct 29, 2024

Non-evacuated urine specimen container IVD, no additive

Manufacturer:

ZRT Laboratory

Type:

In Vitro Diagnostic Device

Registration Date:

Oct 29, 2024

General specimen container IVD, no additive/medium

Manufacturer:

ZRT Laboratory

Type:

In Vitro Diagnostic Device

Registration Date:

Oct 29, 2024

Pulmonary resuscitation feedback device sensor

Manufacturer:

ARCHEON

Type:

General Medical Device

Registration Date:

Oct 4, 2024

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

Manufacturer:

Deldent Ltd

Type:

General Medical Device

Registration Date:

Oct 4, 2024

Dental abrasive air jet system control unit

Manufacturer:

Deldent Ltd

Type:

General Medical Device

Registration Date:

Oct 4, 2024

Pulmonary resuscitation feedback device

Manufacturer:

ARCHEON

Type:

General Medical Device

Registration Date:

Oct 4, 2024

X-ray image interpretive software

Manufacturer:

Lunit Inc.

Type:

General Medical Device

Registration Date:

Sep 29, 2024

Cell morphology analyser IVD, automated/semi-automated

Manufacturer:

Scopio Labs Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

External defibrillation electrode, adult, single-use

Manufacturer:

Progetti S.r.l

Type:

General Medical Device

Registration Date:

Sep 24, 2024

External defibrillation electrode, paediatric, single-use

Manufacturer:

Progetti S.r.l

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Glycated haemoglobin (HbA1c) IVD, control

Manufacturer:

OSANG Healthcare Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 23, 2024

Glycated haemoglobin (HbA1C) analyser IVD

Manufacturer:

OSANG Healthcare Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 23, 2024

Medical device disinfection agent

Manufacturer:

LABORATOIRE HUCKERT'S INTERNATIONAL

Type:

General Medical Device

Registration Date:

Jul 31, 2024

Medical device cleaning/disinfection wipe

Manufacturer:

LABORATOIRE HUCKERT'S INTERNATIONAL

Type:

General Medical Device

Registration Date:

Jul 31, 2024

Medical device cleaning agent

Manufacturer:

LABORATOIRE HUCKERT'S INTERNATIONAL

Type:

General Medical Device

Registration Date:

Jul 31, 2024

Medical device disinfection agent

Manufacturer:

LABORATOIRE HUCKERT'S INTERNATIONAL

Type:

General Medical Device

Registration Date:

Jul 31, 2024

Carbide dental bur, reusable

Manufacturer:

SS White Burs, Inc.

Type:

General Medical Device

Registration Date:

Jul 21, 2024

Inspiratory line humidification chamber, single-use

Manufacturer:

TELESAIR Inc

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Dermal tissue reconstructive material, microbe-derived, anaesthetic

Manufacturer:

VIDA S.R.L.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

CPAP/BPAP nasal mask, reusable

Manufacturer:

Suzhou Yuyue Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Home CPAP unit

Manufacturer:

Suzhou Yuyue Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Peripheral intravenous cannula

Manufacturer:

Troge Medical GmbH

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Insulin syringe/needle, basic

Manufacturer:

Troge Medical GmbH

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Straight/elbow breathing circuit connector, reusable

Manufacturer:

Vincent Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Ventilator breathing circuit, single-use

Manufacturer:

Vincent Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Physical therapy transcutaneous neuromuscular electrical stimulation system

Manufacturer:

Virility Medical Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

X-ray image interpretive software

Manufacturer:

VUNO INC

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Straight/elbow breathing circuit connector, single-use

Manufacturer:

Vincent Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Basic intravenous administration set, noninvasive

Manufacturer:

TANAPHAR JOINT STOCK COMPANY

Type:

General Medical Device

Registration Date:

Apr 11, 2024

General-purpose syringe, single-use

Manufacturer:

TANAPHAR JOINT STOCK COMPANY

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Blood donor set, single-pack

Manufacturer:

Troge Medical GmbH

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Dermal tissue reconstructive material, microbe-derived

Manufacturer:

VIDA S.R.L.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Anaesthesia breathing circuit, reusable

Manufacturer:

Vincent Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Anaesthesia breathing circuit, single-use

Manufacturer:

Vincent Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Inspiratory/expiratory limb respiratory tubing, reusable

Manufacturer:

Vincent Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Ventilator breathing circuit, single-use

Manufacturer:

Vincent Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Radiology DICOM image processing application software

Manufacturer:

VUNO INC

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Ultraviolet phototherapy unit, home-use

Manufacturer:

Xuzhou Kernel Medical Equipment Co.,Ltd

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Hypodermic needle, single-use

Manufacturer:

Troge Medical GmbH

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Metered-delivery hypodermic syringe

Manufacturer:

Troge Medical GmbH

Type:

General Medical Device

Registration Date:

Apr 11, 2024

External pledget

Manufacturer:

VIDA S.R.L.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Home BPAP unit

Manufacturer:

Suzhou Yuyue Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Retinal image analysis software

Manufacturer:

VUNO INC

Type:

General Medical Device

Registration Date:

Apr 11, 2024

CPAP/BPAP face mask, reusable

Manufacturer:

Suzhou Yuyue Medical Technology Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Heated respiratory humidifier

Manufacturer:

Vincent Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Inspiratory line humidification chamber, single-use

Manufacturer:

Vincent Medical Manufacturing Co., Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Metered dose inhaler

Manufacturer:

Syqe Medical Ltd.

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Professional high-flow respiratory unit, humidifying

Manufacturer:

TELESAIR Inc

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Basic intravenous administration set, noninvasive

Manufacturer:

Troge Medical GmbH

Type:

General Medical Device

Registration Date:

Apr 11, 2024

Coagulation analyser IVD, point-of-care, battery-powered

Manufacturer:

Universal Biosensors Pty Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Feb 23, 2024

Ferritin IVD, kit, fluorescent immunoassay

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Mar 22, 2023

Heating block IVD

Manufacturer:

Boditech Med Inc.

Type:

General Medical Device

Registration Date:

Mar 22, 2023

Multiple form 25-hydroxy Vitamin D IVD, reagent

Manufacturer:

Boditech Med Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Mar 22, 2023

Prothrombin time (PT) IVD, reagent

Manufacturer:

Universal Biosensors Pty Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 18, 2022

Prothrombin time (PT) IVD, control

Manufacturer:

Universal Biosensors Pty Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 18, 2022

Coagulation analyser IVD, point-of-care, battery-powered

Manufacturer:

Universal Biosensors Pty Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 18, 2022

Resin artificial teeth

Manufacturer:

YAMAHACHI DENTAL MFG., CO.

Type:

General Medical Device

Registration Date:

Jan 17, 2022

Preformed dental crown, permanent

Manufacturer:

YAMAHACHI DENTAL MFG., CO.

Type:

General Medical Device

Registration Date:

Jan 17, 2022

Medical device adhesive

Manufacturer:

Nyxoah SA

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Nov 12, 2021

Implantable sleep apnoea treatment system, fixed-rate

Manufacturer:

Nyxoah SA

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Nov 12, 2021

Implantable sleep apnoea treatment system pulse generator

Manufacturer:

Nyxoah SA

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Nov 12, 2021

Implantable sleep apnoea treatment system programmer/charger

Manufacturer:

Nyxoah SA

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Nov 12, 2021

Noninvasive device battery charger

Manufacturer:

Nyxoah SA

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Nov 12, 2021

Implantable sleep apnoea treatment system programmer/charger

Manufacturer:

Nyxoah SA

Type:

Active implantable device (Directive 90/385/EEC only)

Registration Date:

Nov 12, 2021

Electrochemical immunoassay analyser IVD

Manufacturer:

Canary Global Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 21, 2021

Alternating-pressure chair cushion, reusable

Manufacturer:

Carilex Medical Inc.

Type:

General Medical Device

Registration Date:

Aug 26, 2021

Alternating-pressure bed mattress overlay system

Manufacturer:

Carilex Medical Inc.

Type:

General Medical Device

Registration Date:

Aug 26, 2021

Alternating-pressure bed mattress overlay system

Manufacturer:

Carilex Medical Inc.

Type:

General Medical Device

Registration Date:

Aug 26, 2021

Alternating-pressure chair cushion, reusable

Manufacturer:

Carilex Medical Inc.

Type:

General Medical Device

Registration Date:

Aug 26, 2021

Orthotic shoe, non-customized

Manufacturer:

BIOMEDICAL SHOES S.L.

Type:

General Medical Device

Registration Date:

Aug 17, 2021

Screw endosteal dental implant, two-piece

Manufacturer:

HIOSSEN, Inc.

Type:

General Medical Device

Registration Date:

Apr 29, 2021

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

Last updated: December 2025