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Qarad UK Ltd.

Authorized Representative in the United Kingdom

8 Northumberland Ave

Westminster, England, United Kingdom

Postcode: WC2N 5BY

Relationship Type: UK Responsible Person
1329 Products Represented
105 Manufacturers
Total Products
1329
Manufacturers
105
Device Types
2
Generic Names
871
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (1329)
Complete portfolio registered with MHRA

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, kit, rapid ICT, clinical

Manufacturer:

BIOSYNEX SWISS SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOSYNEX SWISS SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-P1 red blood cell grouping IVD, antibody

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood group antigen typing reagent IVD

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple immunohaematology test IVD, control

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Papain immunohaematology reagent IVD

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clinical specimen extraction buffer IVD

Manufacturer:

Eurospital S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clinical specimen extraction buffer IVD

Manufacturer:

Eurospital S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coeliac disease genetic risk factor IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Eurospital S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Eurospital S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gliadin antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Eurospital S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tissue transglutaminase antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Eurospital S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Aidian Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Capillary blood collection tube IVD, lithium heparin

Manufacturer:

Aidian Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, control

Manufacturer:

Aidian Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Photometric/spectroscopic immunoassay analyser IVD

Manufacturer:

Aidian Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOSYNEX SWISS SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental cavity varnish

Manufacturer:

Scientific Pharmaceuticals, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Temporary dental crown/bridge

Manufacturer:

Scientific Pharmaceuticals, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Coagulation analyser IVD, laboratory

Manufacturer:

HemoSonics LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Activated partial thromboplastin time (APTT) IVD, reagent

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-Mullerian hormone (AMH) IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-2-microglobulin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Carcinoembryonic antigen (CEA) IVD, control

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Carcinoembryonic antigen (CEA) IVD, kit, fluorescent immunoassay

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus antigen IVD, reagent

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ethanol (ETOH) IVD, kit, rapid spectrophotometry, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free triiodothyronine (FT3) IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori total antibody IVD, reagent

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis E virus immunoglobulin M (IgM) antibody IVD, reagent

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methamphetamine-specific IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microalbumin IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, control

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple coagulation factor IVD, control

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, control

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neisseria gonorrhoeae antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Neutrophil gelatinase-associated lipocalin (NGAL) IVD, kit, fluorescent immunoassay

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Plasmodium falciparum antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prothrombin time (PT) IVD, reagent

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Serum amyloid A IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thrombin time (TT) IVD, reagent

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tricyclic antidepressant IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin T IVD, kit, fluorescent immunoassay

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ultraviolet-visible spectrophotometer IVD

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ultraviolet-visible spectrophotometer IVD

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

LumiQuick Diagnostics Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tricyclic antidepressant IVD, kit, rapid ICT, clinical

Manufacturer:

LumiQuick Diagnostics Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clinical management support software IVD

Manufacturer:

Nalagenetics Pte Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Absorbent underpad, non-antimicrobial, single-use

Manufacturer:

CLEANIS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Absorbent underpad, non-antimicrobial, single-use

Manufacturer:

CLEANIS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Absorbent underpad, non-antimicrobial, single-use

Manufacturer:

CLEANIS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Synthetic polymer semi-permeable film dressing, adhesive

Manufacturer:

BEDAL NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dressing-fixation skin adhesive tape, silicone

Manufacturer:

Reskin Medical NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Scar management dressing, reusable

Manufacturer:

Reskin Medical NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Synthetic polymer semi-permeable film dressing, wound-nonadherent

Manufacturer:

Reskin Medical NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Synthetic polymer semi-permeable film dressing, wound-nonadherent

Manufacturer:

Reskin Medical NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thermo-mechanical skin surface treatment system

Manufacturer:

GMV srl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Autotransfusion system blood collection/processing pump

Manufacturer:

Quince Therapeutics S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Autotransfusion system blood component processing set

Manufacturer:

Quince Therapeutics S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Autotransfusion system blood component processing set

Manufacturer:

Quince Therapeutics S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Breath specimen container IVD

Manufacturer:

Commonwealth Diagnostics International Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clinical management support software

Manufacturer:

Tucuvi Care, S.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Specimen information management system IVD

Manufacturer:

Inpeco SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, kit, rapid ICT, clinical

Manufacturer:

ProciseDx Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Optical laboratory instrument performance standard calibrator/control IVD, single-use

Manufacturer:

ProciseDx Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antibody IVD, control

Manufacturer:

OraSure Technologies, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

OraSure Technologies, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing

Manufacturer:

OraSure Technologies, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oral/upper respiratory tract specimen collection kit

Manufacturer:

OraSure Technologies, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oral/upper respiratory tract specimen collection kit IVD, clinical

Manufacturer:

OraSure Technologies, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adeno-associated virus neutralizing antibody IVD, kit, bioassay

Manufacturer:

Precision for Medicine

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen collection kit IVD, clinical

Manufacturer:

Precision for Medicine

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Atomo Diagnostics Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing

Manufacturer:

Atomo Diagnostics Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus total antibody IVD, control

Manufacturer:

bioLytical Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human genomic analysis interpretive software IVD

Manufacturer:

CareDx Pty Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fixed patient lifting system, electrically-powered

Manufacturer:

Handi-Move NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile patient lifting system, electrically-powered

Manufacturer:

Handi-Move NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile patient lifting system, electrically-powered

Manufacturer:

Handi-Move NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient lifting system bath chair

Manufacturer:

Handi-Move NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient lifting system divided leg sling

Manufacturer:

Handi-Move NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient lifting system lift pants

Manufacturer:

Handi-Move NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Shenzhen Tisenc Medical Devices Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

Shenzhen Tisenc Medical Devices Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General internal orthopaedic fixation system implantation kit

Manufacturer:

Groupe Lépine

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medullary canal orthopaedic reamer, flexible

Manufacturer:

Groupe Lépine

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Metacarpal prosthesis

Manufacturer:

Groupe Lépine

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic bone pin, non-bioabsorbable

Manufacturer:

Groupe Lépine

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic cement dispenser

Manufacturer:

Groupe Lépine

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic surgical procedure kit, non-medicated, single-use

Manufacturer:

Groupe Lépine

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

LumiQuick Diagnostics Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

LumiQuick Diagnostics Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cotinine IVD, kit, rapid ICT, clinical

Manufacturer:

LumiQuick Diagnostics Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple alcohol IVD, kit, rapid ICT, clinical

Manufacturer:

LumiQuick Diagnostics Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

LumiQuick Diagnostics Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oxycodone IVD, kit, rapid ICT, clinical

Manufacturer:

LumiQuick Diagnostics Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

LumiQuick Diagnostics Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical

Manufacturer:

LumiQuick Diagnostics Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal specimen collection kit IVD, home-use

Manufacturer:

Mainz Biomed Germany GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer-related multiple gene mutation profile kit IVD

Manufacturer:

Myriad Genetic Laboratories, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human infectome analysis interpretive software IVD

Manufacturer:

Noscendo GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Ophiomics - Investigação e Desenvolvimento em Biotecnologia, S.A. (Ophiomics)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human genomic analysis interpretive software IVD

Manufacturer:

Takara Bio USA, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bone awl, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Device sterilization/disinfection container, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Manual orthopaedic bender, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic fixation plate tensioner

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drill guide, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

T-cell receptor excision circle (TREC) IVD, kit, nucleic acid technique (NAT)

Manufacturer:

ImmunoIVD AB

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide digital imaging scanner IVD

Manufacturer:

Invenio Imaging, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer risk assessment interpretive software IVD

Manufacturer:

Genomic Health, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Agar medium preparation kit IVD

Manufacturer:

Gradientech AB

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antimicrobial susceptibility analyser IVD

Manufacturer:

Gradientech AB

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antibacterial susceptibility testing kit IVD

Manufacturer:

Gradientech AB

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide digital imaging scanner IVD

Manufacturer:

Grundium Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide digital imaging scanner IVD

Manufacturer:

Grundium Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-fetoprotein (AFP) IVD, control

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Barbiturate IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, fluorescent immunoassay

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia trachomatis antigen IVD, reagent

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cocaine/cocaine metabolite IVD, reagent

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatine kinase myocardial isoenzyme (CKMB) IVD, control

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cystatin C IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, kit, fluorescent immunoassay

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Estradiol (oestradiol) (E2) IVD, reagent

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fatty acid binding protein (FABP) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free (unbound) prostate specific antigen (fPSA) IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free thyroxine (FT4) IVD, kit, fluorescent immunoassay

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human chorionic gonadotropin beta-core fragment IVD, control

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ketamine/ketamine metabolite IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microalbumin IVD, control

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoglobin IVD, kit, fluorescent immunoassay

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Plasmodium falciparum antigen IVD, reagent

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, control

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procalcitonin (PCT) IVD, kit, fluorescent immunoassay

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Progesterone IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prolactin IVD, kit, fluorescent immunoassay

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cortisol IVD, control

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total prostate specific antigen (tPSA) IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total thyroxine (TT4) IVD, kit, fluorescent immunoassay

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tramadol IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin I IVD, kit, fluorescent immunoassay

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ultraviolet-visible spectrophotometer IVD

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen container IVD, no additive/medium

Manufacturer:

DNA Genotek Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

DNA Genotek Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oral/respiratory tract specimen container IVD, additive/medium

Manufacturer:

DNA Genotek Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oral/respiratory tract specimen container IVD, additive/medium

Manufacturer:

DNA Genotek Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine specimen collection kit IVD

Manufacturer:

DNA Genotek Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Analytical scalp electrode, single-use

Manufacturer:

Prolira B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Breath specimen container IVD

Manufacturer:

Commonwealth Diagnostics International Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cell-mediated host immune response marker IVD, calibrator

Manufacturer:

MeMed Diagnostics Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid

Manufacturer:

MeMed Diagnostics Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cell-mediated host immune response marker IVD, control

Manufacturer:

MeMed Diagnostics Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Biological stain IVD

Manufacturer:

Merlin Biomedical (Xiamen) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen container IVD, additive/medium

Manufacturer:

Merlin Biomedical (Xiamen) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Merlin Biomedical (Xiamen) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Merlin Biomedical (Xiamen) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Merlin Biomedical (Xiamen) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Merlin Biomedical (Xiamen) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid sample preparation instrument IVD

Manufacturer:

Merlin Biomedical (Xiamen) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Merlin Biomedical (Xiamen) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

Stratec Consumables GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Enzyme immunoassay (EIA) analyser IVD

Manufacturer:

STRATEC SE

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Histology/cytology/microbiology image-analysis interpretive software IVD

Manufacturer:

Invenio Imaging, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Genomic Health, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Coagulation analyser IVD, laboratory

Manufacturer:

HemoSonics LLC

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Activated clotting time (ACT) IVD, reagent

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adenovirus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, control

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Complexed prostate specific antigen (cPSA) IVD, control

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, control

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Enterovirus immunoglobulin M (IgM) antibody (serotypes 68-71) IVD, reagent

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ethyl glucuronide (EtG) IVD, reagent

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fentanyl IVD, reagent

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ferritin IVD, kit, fluorescent immunoassay

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fibrinogen assay (factor I) IVD, reagent

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fluorescent immunoassay analyser IVD, laboratory

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Follicle stimulating hormone (FSH) IVD, reagent

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, control

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis A virus immunoglobulin M (IgM) antibody IVD, reagent

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Interleukin-6 (IL-6) IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methadone IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cardiac marker IVD, kit, fluorescent immunoassay

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, reagent

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple human hormone IVD, control

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoglobin IVD, control

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rotavirus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cortisol IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total testosterone IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total triiodothyronine (TT3) IVD, kit, fluorescent immunoassay

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin I IVD, control

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Troponin I IVD, kit, rapid ICT, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

LumiQuick Diagnostics Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fentanyl IVD, kit, rapid ICT, clinical

Manufacturer:

LumiQuick Diagnostics Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ketamine/ketamine metabolite IVD, kit, rapid ICT, clinical

Manufacturer:

LumiQuick Diagnostics Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Methadone IVD, kit, rapid ICT, clinical

Manufacturer:

LumiQuick Diagnostics Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tramadol IVD, kit, rapid ICT, clinical

Manufacturer:

LumiQuick Diagnostics Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Nucleix Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer risk assessment interpretive software IVD

Manufacturer:

Ophiomics - Investigação e Desenvolvimento em Biotecnologia, S.A. (Ophiomics)

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple congenital aneuploidy screening IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Takara Bio USA, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Electroencephalographic monitoring system

Manufacturer:

Prolira B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Attendant-only-propelled wheelchair, bariatric

Manufacturer:

ACIME FRAME SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Examination/treatment table, manual

Manufacturer:

ACIME FRAME SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General examination/treatment chair, electric

Manufacturer:

ACIME FRAME SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Transport wheelchair, non-collapsible

Manufacturer:

ACIME FRAME SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, rapid ICT, self-testing

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clostridium tetani toxin immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, self-testing

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ferritin IVD, kit, rapid ICT, clinical

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, kit, rapid ICT, self-testing

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori total antibody IVD, kit, immunoblot

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urine albumin IVD, kit, rapid colorimetric, clinical

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD

Manufacturer:

Accelerate Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Orthopaedic fixation plate, non-bioabsorbable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implantable-device cutter

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic wire crimper

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Total temporomandibular joint prosthesis

Manufacturer:

CADSkills BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Transgingival implant

Manufacturer:

CADSkills BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pupillometer, electrically-powered

Manufacturer:

Oculox Technologies SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Omega Bio-tek

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid sample preparation instrument IVD

Manufacturer:

Omega Bio-tek

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bactericidal/permeability-increasing protein anti-neutrophil cytoplasmic antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-2-microglobulin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Complement component C1q IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycoprotein-210 (gp210) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Histone antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunoassay instrument/analyser general performance control kit IVD

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Insulin antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Measles virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple liver disease-associated antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mumps virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mutated citrullinated vimentin (MCV) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleosomal antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sp-100 protein antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Varicella-zoster virus (VZV) immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Custom-made upper-limb orthosis

Manufacturer:

Spentys

Type:

General Medical Device

Registration Date:

Nov 26, 2024

HLA class I & II antibody screening IVD, kit, multiplex

Manufacturer:

One Lambda, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

One Lambda, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tau protein IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amyloid B component IVD, control

Manufacturer:

Fujirebio Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

ABO/Rh multiple blood grouping IVD, kit, agglutination

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Acrylic resin embedding kit IVD

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-B red blood cell grouping IVD, antibody

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human genomic analysis interpretive software

Manufacturer:

One Lambda, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tau protein IVD, reagent

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Electrical assistive bed

Manufacturer:

tecfor care GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

MASMEC S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid

Manufacturer:

MeMed Diagnostics Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cell-mediated host immune response marker IVD, control

Manufacturer:

MeMed Diagnostics Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Merlin Biomedical (Xiamen) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Merlin Biomedical (Xiamen) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Merlin Biomedical (Xiamen) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Merlin Biomedical (Xiamen) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Merlin Biomedical (Xiamen) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Merlin Biomedical (Xiamen) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Custom-made lower-limb orthosis

Manufacturer:

Spentys

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Human papillomavirus (HPV) nucleic acid IVD, probe

Manufacturer:

Advanced Cell Diagnostics, Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOTYPE GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOSYNEX SWISS SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOSYNEX SWISS SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOSYNEX SWISS SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOSYNEX SWISS SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fluorescent immunoassay analyser IVD, point-of-care

Manufacturer:

ProciseDx Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

DNA blocking reagent IVD

Manufacturer:

One Lambda, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Electrophoresis chamber IVD

Manufacturer:

One Lambda, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HLA class I & II antibody screening IVD, kit, multiplex

Manufacturer:

One Lambda, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

One Lambda, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tau protein IVD, reagent

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Body/limb elastic exerciser

Manufacturer:

MVS In Motion

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Finger/hand exerciser

Manufacturer:

MVS In Motion

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Finger/hand exerciser

Manufacturer:

MVS In Motion

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Percussion hammer, manual, reusable

Manufacturer:

MVS In Motion

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pinwheel aesthesiometer

Manufacturer:

MVS In Motion

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pressure bandage, non-latex, single-use

Manufacturer:

MVS In Motion

Type:

General Medical Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Aidian Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Collagen type I cross-linked C-telopeptide IVD, kit, radioimmunoassay

Manufacturer:

Aidian Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, control

Manufacturer:

Aidian Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, control

Manufacturer:

Aidian Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal specimen container IVD, transport buffer/medium

Manufacturer:

Aidian Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Aidian Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple formulation agar culture medium IVD

Manufacturer:

Aidian Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procollagen type III N-terminal propeptide (PIIINP) IVD, kit, radioimmunoassay

Manufacturer:

Aidian Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total haemoglobin (totHb) IVD, control

Manufacturer:

Aidian Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal specimen container IVD, DNA preservation solution

Manufacturer:

DNA Genotek Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oral/respiratory tract specimen container IVD, additive/medium

Manufacturer:

DNA Genotek Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oral/upper respiratory tract specimen collection swab

Manufacturer:

DNA Genotek Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oral/upper respiratory tract specimen collection swab

Manufacturer:

DNA Genotek Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Flexible video bronchoscope, reusable

Manufacturer:

Lys Medical SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cavity-wound management dressing, antimicrobial

Manufacturer:

ManukaMed Limited Partnership

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dry skin moisture barrier dressing

Manufacturer:

ManukaMed Limited Partnership

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

Manufacturer:

ManukaMed Limited Partnership

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wound-nonadherent dressing, permeable, antimicrobial

Manufacturer:

ManukaMed Limited Partnership

Type:

General Medical Device

Registration Date:

Nov 26, 2024

ABO multiple blood grouping IVD, kit, agglutination

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-A red blood cell grouping IVD, antibody

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-AB red blood cell grouping IVD, antibody

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-M red blood cell grouping IVD, lectin

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-N red blood cell grouping IVD, antibody

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antisera matrix (non-reactive) IVD, control

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antisera matrix (non-reactive) IVD, control

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple immunohaematology test IVD, control

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Carbon dioxide absorbent solution IVD

Manufacturer:

Fujirebio Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

Diatron MI Plc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clinical specimen extraction buffer IVD

Manufacturer:

Eurospital S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, kit, agglutination

Manufacturer:

Eurospital S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, reagent

Manufacturer:

Eurospital S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HLA class II antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Eurospital S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tissue transglutaminase antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Eurospital S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

Fujirebio Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amyloid B component IVD, reagent

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay container IVD, single-use

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cystic fibrosis IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Line probe assay interpretation template IVD

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anoscope, single-use

Manufacturer:

F Care Systems NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Percutaneous radio-frequency ablation system generator

Manufacturer:

F Care Systems NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Photometric/spectroscopic immunoassay analyser IVD

Manufacturer:

BIOSYNEX TECHNOLOGIES GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group B Streptococcus nucleic acid IVD, reagent

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, kit, rapid ICT, clinical

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, kit, fluorescent immunoassay

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Medicine chamber spacer, reusable

Manufacturer:

BIOSYNEX SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multiple faecal parasite nucleic acid IVD, kit, nucleic acid technique (NAT)

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple faecal parasite nucleic acid IVD, reagent

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple imminent labour-associated marker IVD, kit, rapid ICT, clinical

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Norovirus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, calibrator

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, reagent

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, kit, agglutination

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal specimen collection kit IVD, clinical

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, fluorescent immunoassay

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Islet cell antibody IVD, control

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Liver-kidney microsome 1 antibody (anti-LKM1) IVD, control

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mitochondrial antibody M2 (anti-Mi2) IVD, kit, fluorescent immunoassay

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyser IVD, laboratory

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyser IVD, laboratory

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyser IVD, laboratory

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Native DNA antibody (anti-nDNA) IVD, control

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Breath specimen container IVD

Manufacturer:

Commonwealth Diagnostics International Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hepatitis C virus antibody/antigen IVD, control

Manufacturer:

OraSure Technologies, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General-purpose patient lifting system sling/harness

Manufacturer:

Handi-Move NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile patient lifting system, electrically-powered

Manufacturer:

Handi-Move NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile patient lifting system, manual

Manufacturer:

Handi-Move NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Overhead track patient lifting/transfer system

Manufacturer:

Handi-Move NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Overhead track patient lifting/transfer system

Manufacturer:

Handi-Move NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Overhead track patient lifting/transfer system

Manufacturer:

Handi-Move NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient lifting system amputee sling

Manufacturer:

Handi-Move NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient lifting system hammock sling

Manufacturer:

Handi-Move NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stand-up mobile patient lifting system sling/harness

Manufacturer:

Handi-Move NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nucleic acid hybridization detection IVD, control

Manufacturer:

Advanced Cell Diagnostics, Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ferritin IVD, kit, rapid ICT, clinical

Manufacturer:

Affimedix, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Affimedix, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOSYNEX SWISS SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

D-dimer IVD, kit, rapid ICT, clinical

Manufacturer:

BIOSYNEX SWISS SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Legionella pneumophila antigen IVD, kit, rapid ICT, clinical

Manufacturer:

BIOSYNEX SWISS SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOSYNEX SWISS SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Medical honey liquid barrier dressing

Manufacturer:

ManukaMed Limited Partnership

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD

Manufacturer:

Fujirebio Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Foundation Medicine, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Evacuated blood collection tube IVD, anticoagulant/cell preservative

Manufacturer:

Foundation Medicine, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered wash solution IVD

Manufacturer:

Fujirebio Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amyloid B component IVD, calibrator

Manufacturer:

Fujirebio Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory analyser cuvette IVD, single-use

Manufacturer:

Fujirebio Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pipette tip IVD

Manufacturer:

Fujirebio Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tau protein IVD, calibrator

Manufacturer:

Fujirebio Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tau protein IVD, control

Manufacturer:

Fujirebio Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Digital imaging scanner/reader calibration card IVD

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human placental alkaline phosphatase (hPLAP) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Line probe assay interpretation template IVD

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tau protein IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Endoscopic electrosurgical electrode, monopolar, single-use

Manufacturer:

F Care Systems NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Percutaneous radio-frequency ablation system generator

Manufacturer:

F Care Systems NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

DNA Genotek Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oral/upper respiratory tract specimen collection swab

Manufacturer:

DNA Genotek Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Urine specimen collection kit IVD

Manufacturer:

DNA Genotek Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Finger/hand exerciser

Manufacturer:

MVS In Motion

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Paediatric dorsiflexion slant board

Manufacturer:

MVS In Motion

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Pressure bandage, non-latex, single-use

Manufacturer:

MVS In Motion

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Implantable orthopaedic fixation device connection screw

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Orthopaedic implantation sleeve, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wire/ligature passer, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Multiple immunosuppressant therapeutic drug monitoring IVD, control

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Citrate IVD, kit, spectrophotometry

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ethyl glucuronide (EtG) IVD, control

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ethyl glucuronide (EtG) IVD, kit, mass spectrometry

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free cortisol/cortisone IVD, calibrator

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free cortisol/cortisone IVD, kit, liquid chromatography/mass spectrometry (LC/MS)

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HVA/VMA/5HIAA IVD, calibrator

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Levetiracetam therapeutic drug monitoring IVD, kit, liquid chromatography

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple biogenic amine neurotransmitter IVD, calibrator

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, control

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple steroid hormone IVD, kit, mass spectrometry

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple vitamin IVD, calibrator

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Organic solvent metabolite IVD, kit, liquid chromatography

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oxalate IVD, kit, spectrophotometry

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total porphyrin (coproporphyrin/uroporphyrin) IVD, kit, liquid chromatography

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vitamin C (ascorbic acid) IVD, calibrator

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Blood test-based differential diagnosis interpretive software IVD

Manufacturer:

Fibronostics US Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

Stratec Consumables GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

STRATEC SE

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen microscopy slide IVD, single-use

Manufacturer:

Invenio Imaging, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Hospital stretcher, manual

Manufacturer:

ACIME FRAME SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hospital stretcher, powered

Manufacturer:

ACIME FRAME SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Alpha-fetoprotein/insulin-like growth factor binding protein 1 IVD, kit, rapid ICT, clinical

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal specimen collection kit IVD, home-use

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ferritin IVD, kit, fluorescent immunoassay

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fibrinogen assay (factor I) IVD, reagent

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gliadin antibody IVD, kit, rapid ICT, self-testing

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Endomysium antibody (EMA) IVD, control

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, control

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glomerular basement membrane antibody (Goodpasture antibody) IVD, control

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, control

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, control

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple antinuclear antibody (ANA) screening IVD, reagent

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyser IVD, laboratory

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phosphate buffer/Sorenson buffer solution IVD

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Skin antibody IVD, control

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Skin antibody IVD, kit, fluorescent immunoassay

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Infrared patient thermometer, skin

Manufacturer:

Nexmed Technology Co.,Ltd.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sleep disorder interpretive software, patient-use

Manufacturer:

NOMICS SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wearable multiple physiological parameter recorder, reusable

Manufacturer:

NOMICS SA

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Parathyroid hormone (PTH) IVD, control

Manufacturer:

NBCL B.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay

Manufacturer:

NBCL B.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid amplification mastermix kit IVD

Manufacturer:

Natera, Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Centromere antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Enzyme immunoassay (EIA) analyser IVD

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Enzyme immunoassay (EIA) analyser IVD

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lactoferrin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Liver-kidney microsome 1 antibody (anti-LKM1) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Yersinia species immunoglobulin A (IgA)/IgG antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prothrombin antibody (anti-prothrombin) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Saccharomyces cerevisiae total antibody IVD, kit enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Single stranded DNA antibody (anti-ssDNA) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dental implant abutment analog, scanning

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant holding endpiece

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation depth/angle gauge, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation drilling template guide-sleeve

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental soft-tissue coring punch, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental torque wrench

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fixture/appliance dental drill bit, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, two-piece

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical countersink, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument/implant depth limiter

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical power tool hand-switch

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Carpal scaphoid prosthesis

Manufacturer:

Groupe Lépine

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Fluted surgical drill bit, reusable

Manufacturer:

Groupe Lépine

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Mobile patient lifting system, electrically-powered

Manufacturer:

Handi-Move NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Overhead track patient lifting/transfer system

Manufacturer:

Handi-Move NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Patient lifting system stretcher

Manufacturer:

Handi-Move NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Stand-up mobile patient lifting system, electrically-powered

Manufacturer:

Handi-Move NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Lipoprotein-associated phospholipase A2 (Lp-PLA2) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Tisenc Medical Devices Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General examination/treatment chair, manual

Manufacturer:

ACIME FRAME SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ACIME FRAME SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus antigen IVD, kit, agglutination

Manufacturer:

Aidian Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, control

Manufacturer:

Aidian Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Aidian Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

Manufacturer:

Aidian Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Capillary blood transfer tube IVD, EDTA

Manufacturer:

Aidian Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, kit, nephelometry/turbidimetry

Manufacturer:

Aidian Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple formulation agar culture medium IVD

Manufacturer:

Aidian Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple formulation agar culture medium IVD

Manufacturer:

Aidian Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Procollagen type I N-terminal propeptide (PINP) IVD, kit, radioimmunoassay

Manufacturer:

Aidian Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group B Streptococcus nucleic acid IVD, control

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bladder tumour associated antigen IVD, kit, rapid ICT, clinical

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Molecular grade lysis reagent IVD

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Photometric/spectroscopic immunoassay analyser IVD

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Photometric/spectroscopic immunoassay analyser IVD

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Photometric/spectroscopic immunoassay analyser IVD

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vaginal pH screening IVD, kit, rapid colorimetric, self-testing

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adrenal antibody IVD, kit, fluorescent immunoassay

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, control

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Citrate IVD, kit, enzyme spectrophotometry

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, calibrator

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glomerular basement membrane antibody (Goodpasture antibody) IVD, reagent

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Intrinsic factor/parietal cell antibody IVD, control

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Islet cell antibody IVD, kit, fluorescent immunoassay

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscopy mounting medium IVD

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Mitochondrial antibody M2 (anti-Mi2) IVD, control

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple clinical chemistry analyser IVD, laboratory

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Smooth muscle antibody IVD, control

Manufacturer:

BIOSYSTEMS S.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HVA/VMA/5HIAA IVD, kit, liquid chromatography

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Levetiracetam therapeutic drug monitoring IVD, calibrator

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Levetiracetam therapeutic drug monitoring IVD, control

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Liquid chromatography/mass spectrometry analysis specimen preparation/processing reagent IVD

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Metanephrine IVD, kit, liquid chromatography

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple biogenic amine neurotransmitter IVD, control

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple drugs of abuse IVD, control

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple drugs of abuse IVD, kit, liquid chromatography

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, kit, liquid chromatography/mass spectrometry (LC/MS)

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple gastrointestinal disease marker IVD, calibrator

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple gastrointestinal disease marker IVD, control

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple immunosuppressant therapeutic drug monitoring IVD, calibrator

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple immunosuppressant therapeutic drug monitoring IVD, kit, liquid chromatography/mass spectrometry (LC/MS)

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple steroid hormone IVD, calibrator

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple vitamin IVD, control

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Organic solvent metabolite IVD, calibrator

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Organic solvent metabolite IVD, control

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oxalate IVD, control

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Polycyclic aromatic hydrocarbon (PAH) metabolite IVD, calibrator

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total porphyrin (coproporphyrin/uroporphyrin) IVD, calibrator

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total porphyrin (coproporphyrin/uroporphyrin) IVD, control

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Transferrin/transferrin isoform IVD, control

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vitamin B6 complex group IVD, kit, liquid chromatography

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

BK virus (BKV) nucleic acid IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Aldolase IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antithrombin III (ATIII) IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay container IVD, single-use

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-2-microglobulin IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

BK virus (BKV) nucleic acid IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clinical specimen extraction buffer IVD

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clinical specimen extraction buffer IVD

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood immunoassay analyser IVD

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, kit, rapid ICT, clinical

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fructosamine IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fructosamine IVD, kit, enzyme spectrophotometry

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gamma-glutamyltransferase (GGT) IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glucose IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Homocysteine IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Homocysteine IVD, kit, enzyme spectrophotometry

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human herpesvirus 6 (HHV6) nucleic acid IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Kappa/lambda light chain immunoglobulin IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lactate IVD, kit, enzyme spectrophotometry

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lipase IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lipase IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lipase IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Magnesium (Mg2+) IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple lipid analyte IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pancreatic elastase (PE) IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Plasma protein IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 total antibody IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total bile acid IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total bile acid IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total bile acid IVD, kit, enzyme spectrophotometry

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total lactate dehydrogenase (LDH) IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Triglyceride IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Unsaturated iron binding capacity (UIBC) IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Urea IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer-related multiple gene mutation profile kit IVD

Manufacturer:

SOPHiA GENETICS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human genomic analysis interpretive software IVD

Manufacturer:

SOPHiA GENETICS

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Enzyme immunoassay (EIA) analyser IVD

Manufacturer:

STRATEC SE

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Electroencephalographic monitoring system

Manufacturer:

Prolira B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Adenovirus nucleic acid IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alanine aminotransferase (ALT) IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Albumin IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alkaline phosphatase (ALP) isoenzyme IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-1-acid glycoprotein (orosomucoid) IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-2-macroglobulin IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-hydroxybutyrate dehydrogenase IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ammonia IVD, kit, spectrophotometry

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Angiotensin converting enzyme (ACE) IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay container IVD, single-use

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay container IVD, single-use

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calcium (Ca2+) IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cholinesterase dibucaine number (percentage inhibition) IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clinical specimen extraction buffer IVD

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clinical specimen extraction buffer IVD

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatinine IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cystatin C IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Epstein-Barr virus (EBV) nucleic acid IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood immunoassay analyser IVD

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Haptoglobin IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) total antibody IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) total antibody IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

High density lipoprotein (HDL) cholesterol IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Inorganic phosphate (PO43-) IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Iron IVD, kit, spectrophotometry

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Low density lipoprotein (LDL) cholesterol IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microalbumin IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple respiratory virus nucleic acid IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type clinical chemistry analyte profile IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pancreatic elastase (PE) IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pancreatic elastase (PE) IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phospholipid IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Plasma protein IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Prealbumin (transthyretin) IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pseudocholinesterase IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 total antibody IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total amylase IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total bilirubin IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total creatine kinase (CK) IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Uric acid IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Zinc IVD, kit, spectrophotometry

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Reverse transcription reagent kit IVD

Manufacturer:

Immunexpress Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Genomic Health, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

Gradientech AB

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide digital imaging scanner IVD

Manufacturer:

Grundium Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide digital imaging scanner IVD

Manufacturer:

Grundium Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide digital imaging scanner IVD

Manufacturer:

Grundium Oy

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, control

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, rapid ICT, clinical

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

BIOSYNEX SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Albumin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-fodrin antibody IVD, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

bioLytical Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

CareDx Pty Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Post bone-marrow transplant engraftment study IVD, kit, nucleic acid technique (NAT)

Manufacturer:

CareDx Pty Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cell centrifugation/density gradient separation reagent IVD

Manufacturer:

One Lambda, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Microscope slide stainer IVD

Manufacturer:

One Lambda, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Shenzhen Tisenc Medical Devices Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Tisenc Medical Devices Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Tisenc Medical Devices Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cancer?antigen?19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Tisenc Medical Devices Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dengue virus antigen IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Tisenc Medical Devices Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Shenzhen Tisenc Medical Devices Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Examination/treatment table, line-powered

Manufacturer:

ACIME FRAME SAS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, rapid ICT, self-testing

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amniotic fluid leak detection device IVD

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ferritin IVD, kit, rapid ICT, self-testing

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Gliadin antibody IVD, kit, rapid ICT, self-testing

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple urine analyte IVD, kit, rapid colorimetric, self-testing

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vaginal pH screening IVD, kit, rapid colorimetric, self-testing

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered sample diluent IVD

Manufacturer:

Accelerate Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-A red blood cell grouping IVD, antibody

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-AB red blood cell grouping IVD, antibody

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-B red blood cell grouping IVD, antibody

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anti-CDE red blood cell grouping IVD, antibody

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Antisera matrix (non-reactive) IVD, control

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Bromelin immunohaematology reagent IVD

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rhesus (Rh) phenotype (CcDEe)/Kell phenotype multiple blood grouping IVD, kit, agglutination

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

Diatron MI Plc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Eurospital S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, kit, rapid ICT, clinical

Manufacturer:

Eurospital S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, kit, rapid ICT, clinical

Manufacturer:

Eurospital S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, reagent

Manufacturer:

Eurospital S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, kit, agglutination

Manufacturer:

Eurospital S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pancreatic elastase (PE) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Eurospital S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Eurospital S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Evacuated blood collection tube IVD, anticoagulant/cell preservative

Manufacturer:

Foundation Medicine, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amyloid B component IVD, kit, chemiluminescent immunoassay

Manufacturer:

Fujirebio Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Buffered wash solution IVD

Manufacturer:

Fujirebio Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

Fujirebio Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent substrate reagent IVD

Manufacturer:

Fujirebio Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Tau protein IVD, kit, chemiluminescent immunoassay

Manufacturer:

Fujirebio Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amyloid B component IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amyloid B component IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amyloid B component IVD, reagent

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Blot processor IVD

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cystic fibrosis IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Digital imaging scanner/reader calibration card IVD

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen collection kit

Manufacturer:

APTACA S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General specimen collection kit IVD, clinical

Manufacturer:

APTACA S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

APTACA S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Oral/upper respiratory tract specimen collection kit IVD, clinical

Manufacturer:

APTACA S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bicycle exerciser

Manufacturer:

MVS In Motion

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Body/limb elastic exerciser

Manufacturer:

MVS In Motion

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Hot/cold therapy pack, reusable

Manufacturer:

MVS In Motion

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Medical honey liquid barrier dressing

Manufacturer:

ManukaMed Limited Partnership

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental composite resin

Manufacturer:

Scientific Pharmaceuticals, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental etching solution

Manufacturer:

Scientific Pharmaceuticals, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Thermo-mechanical skin surface treatment system

Manufacturer:

GMV srl

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Mondomed NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Respiratory oxygen therapy physiologic monitor/gas regulator

Manufacturer:

O2matic ApS

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Clinical management support software

Manufacturer:

QAELUM NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Blood storage solution, multi-purpose

Manufacturer:

Quince Therapeutics S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

OraSure Technologies, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oropharyngeal mucosa protection material

Manufacturer:

Lifestream Pharma N.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Parathyroid hormone (PTH) IVD, calibrator

Manufacturer:

NBCL B.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Circulating tumour DNA/RNA IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Natera, Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Evacuated blood collection tube IVD, anticoagulant

Manufacturer:

Natera, Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human genomic analysis interpretive software

Manufacturer:

Natera, Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple congenital aneuploidy screening IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Natera, Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Omega Bio-tek

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Omega Bio-tek

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Omega Bio-tek

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-1-antitrypsin (protease inhibitor) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Annexin V antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cathepsin antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chlamydia trachomatis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clinical specimen extraction buffer IVD

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal specimen collection kit IVD, clinical

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Immunoassay instrument/analyser general performance control kit IVD

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Intrinsic factor/parietal cell antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Liver cytosol-specific antibody type 1 (anti-LC1) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lysozyme (muramidase) anti-neutrophil cytoplasmic antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, control

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parvovirus B19 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phospholipid antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, multiplex

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ribonucleoprotein antibody (anti-RNP) IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Saccharomyces cerevisiae immunoglobulin A (IgA) antibody IVD, kit enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thyroglobulin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Dental drill bit extension

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone trephine, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant abutment analog, scanning

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant abutment analog, scanning

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation depth/angle gauge, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation drilling template guide-sleeve

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implantation drilling template retention pin

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental osteotome

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical drilling suction device

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument/implant depth limiter

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ethyl glucuronide (EtG) IVD, calibrator

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Free cortisol/cortisone IVD, control

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Metanephrine IVD, calibrator

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple biogenic amine neurotransmitter IVD, kit, liquid chromatography

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple biogenic amine neurotransmitter IVD, kit, liquid chromatography/mass spectrometry (LC/MS)

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple drugs of abuse IVD, calibrator

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple form 25-hydroxy Vitamin D IVD, calibrator

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple steroid hormone IVD, control

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple vitamin IVD, kit, liquid chromatography

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oxalate IVD, calibrator

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Polycyclic aromatic hydrocarbon (PAH) metabolite IVD, kit, liquid chromatography

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Transferrin/transferrin isoform IVD, kit, liquid chromatography

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vitamin B1 (thiamine) IVD, kit, liquid chromatography

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vitamin C (ascorbic acid) IVD, control

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Vitamin C (ascorbic acid) IVD, kit, liquid chromatography

Manufacturer:

EUREKA S.R.L. LAB DIVISION

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Adenovirus nucleic acid IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ammonia IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Amylase isoenzyme IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Angiotensin converting enzyme (ACE) IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Angiotensin converting enzyme (ACE) IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Apolipoprotein A-I (Apo A1) IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Apolipoprotein B (Apo B) IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Aspartate aminotransferase (AST) isoenzyme IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay container IVD, single-use

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assay container IVD, single-use

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-2-microglobulin IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

C-reactive protein (CRP) IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Calprotectin IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Ceruloplasmin IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clinical specimen extraction buffer IVD

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Clinical specimen extraction buffer IVD

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Conjugated (direct) bilirubin IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Copper IVD, kit, spectrophotometry

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Creatine kinase myocardial isoenzyme (CKMB) IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cystatin C IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cystatin C IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood immunoassay analyser IVD

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Fructosamine IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Glycated haemoglobin (HbA1c) IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

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:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human herpesvirus 6 (HHV6) nucleic acid IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lipase IVD, kit, enzyme spectrophotometry

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lipoprotein A IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lipoprotein A IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lipoprotein A IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Lithium therapeutic drug monitoring IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple lipid analyte IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoglobin IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Myoglobin IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid amplification mastermix kit IVD

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pancreatic elastase (PE) IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Plasma protein IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rheumatoid factor IVD, calibrator

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rheumatoid factor IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

SARS-CoV-2 nucleic acid IVD, control

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification instrument IVD, manual

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total acid phosphatase (TAP) IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cholesterol lipid IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total protein IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Transferrin IVD, reagent

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

SENTINEL CH. S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Wound-nonadherent dressing, permeable, non-antimicrobial

Manufacturer:

Reskin Medical NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Bone tap, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Craniofacial bone screw, non-bioabsorbable, sterile

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant abutment analog, scanning

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, permanent, preformed

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental prosthesis/implant abutment screw

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental prosthesis/implant abutment screw

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Screw endosteal dental implant, two-piece

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Sliding dental precision attachment

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument handle, non-torque-limiting

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument/implant depth limiter

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument/implant depth limiter

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical screwdriver, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Synthetic bone graft

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Ventilator breathing circuit, reusable

Manufacturer:

Plastiflex Group NV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Wart-removal cryogenic kit

Manufacturer:

Pronova Laboratories BV

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Cardiovascular interpretive screening software

Manufacturer:

Qompium nv

Type:

General Medical Device

Registration Date:

Nov 26, 2024

MRI image interpretive software

Manufacturer:

Quibim, S.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiology DICOM image processing application software

Manufacturer:

Quibim, S.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Radiology DICOM image processing application software

Manufacturer:

Quibim, S.L.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dental acrylic resin

Manufacturer:

Scientific Pharmaceuticals, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Glass ionomer dental cement

Manufacturer:

Scientific Pharmaceuticals, Inc.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polyester suture, non-bioabsorbable, multifilament

Manufacturer:

ImplicitCare, LLC

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Autotransfusion system blood collection/processing pump

Manufacturer:

Quince Therapeutics S.p.A.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Specimen processing instrument IVD

Manufacturer:

Inpeco SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

MeMed Diagnostics Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple cell-mediated host immune response marker IVD, calibrator

Manufacturer:

MeMed Diagnostics Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Merlin Biomedical (Xiamen) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Merlin Biomedical (Xiamen) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Merlin Biomedical (Xiamen) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Merlin Biomedical (Xiamen) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Merlin Biomedical (Xiamen) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

Merlin Biomedical (Xiamen) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

Merlin Biomedical (Xiamen) Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Electrical assistive bed

Manufacturer:

tecfor care GmbH

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Dry skin moisture barrier dressing

Manufacturer:

Grahams Natural Alternatives Pty Ltd

Type:

General Medical Device

Registration Date:

Nov 26, 2024

General internal orthopaedic fixation system implantation kit

Manufacturer:

Groupe Lépine

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Polymer orthopaedic cement restrictor, bioabsorbable

Manufacturer:

Groupe Lépine

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical implant/trial-implant/sizer holder, reusable

Manufacturer:

Groupe Lépine

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Surgical instrument/implant rack

Manufacturer:

Groupe Lépine

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ProciseDx Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal specimen collection kit IVD, clinical

Manufacturer:

ProciseDx Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal specimen collection kit IVD, home-use

Manufacturer:

ProciseDx Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

TNF-alpha inhibitor therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Manufacturer:

ProciseDx Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oropharyngeal mucosa protection material

Manufacturer:

Lifestream Pharma N.V.

Type:

General Medical Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

NBCL B.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cell-free DNA IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Natera, Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Evacuated blood collection tube IVD, anticoagulant/cell preservative

Manufacturer:

Natera, Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

General specimen container IVD, no additive/medium

Manufacturer:

Natera, Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human genomic analysis interpretive software IVD

Manufacturer:

Natera, Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Nucleic acid amplification primer IVD

Manufacturer:

Natera, Inc

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Parvovirus B19 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Phosphatidylserine antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Pipette tip IVD

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Smooth muscle antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Soluble liver antigen/liver pancreas (SLA/LP) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antibody IVD, control

Manufacturer:

bioLytical Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Manufacturer:

bioLytical Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

bioLytical Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, control

Manufacturer:

bioLytical Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Cell-free DNA IVD, kit, nucleic acid technique (NAT)

Manufacturer:

CareDx Pty Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Post-transplant DNA analysis interpretive software IVD

Manufacturer:

CareDx Pty Ltd

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Human genomic analysis interpretive software IVD

Manufacturer:

23andMe, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay

Manufacturer:

Shenzhen Tisenc Medical Devices Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

Shenzhen Tisenc Medical Devices Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

Shenzhen Tisenc Medical Devices Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Shenzhen Tisenc Medical Devices Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Shenzhen Tisenc Medical Devices Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Oral/respiratory tract specimen container IVD, additive/medium

Manufacturer:

APTACA S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Faecal occult blood IVD, kit, rapid ICT, clinical

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Helicobacter pylori antigen IVD, kit, rapid ICT, self-testing

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total cholesterol lipid IVD, kit, rapid colorimetric, self-testing

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Total prostate specific antigen (tPSA) IVD, kit, rapid ICT, self-testing

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Laboratory instrument/analyser application software IVD

Manufacturer:

UgenTec N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry

Manufacturer:

Accelerate Diagnostics, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 26, 2024

Assisted reproduction embryo-assessment software

Manufacturer:

Future Fertility

Type:

General Medical Device

Registration Date:

Nov 26, 2024

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

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

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

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Interleukin-6 (IL-6) IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Multiple cardiac marker IVD, kit, fluorescent immunoassay

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

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

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

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

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Myoglobin IVD, kit, fluorescent immunoassay

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Norovirus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Plasmodium falciparum antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Procalcitonin (PCT) IVD, kit, fluorescent immunoassay

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Progesterone IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

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

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Total cortisol IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

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

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Total triiodothyronine (TT3) IVD, kit, fluorescent immunoassay

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Total haemoglobin (totHb) IVD, kit, spectrophotometry

Manufacturer:

Wrig Nanosystems Private Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Total haemoglobin (totHb) IVD, reagent

Manufacturer:

Wrig Nanosystems Private Limited

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

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

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

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

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

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

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Chlamydia pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

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

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

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

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Insulin IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Enterovirus immunoglobulin M (IgM) antibody (serotypes 68-71) IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Faecal occult blood IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

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

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Gastrin IVD, kit, fluorescent immunoassay

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

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

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Helicobacter pylori total antibody IVD, kit, fluorescent immunoassay

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Ketamine/ketamine metabolite IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Heparin-binding protein IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Free thyroxine (FT4) IVD, kit, fluorescent immunoassay

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

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

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

D-dimer IVD, kit, fluorescent immunoassay

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Calprotectin IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

C-peptide IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Albumin IVD, kit, fluorescent immunoassay

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Adenovirus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

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

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Serum amyloid A IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

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

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

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

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Troponin I IVD, kit, fluorescent immunoassay

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

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

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

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

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Anti-Mullerian hormone (AMH) IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Free triiodothyronine (FT3) IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

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

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Methamphetamine-specific IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Microalbumin IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

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

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Multiple form 25-hydroxy Vitamin D IVD, reagent

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Prolactin IVD, kit, fluorescent immunoassay

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Rotavirus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Thyroglobulin antibody IVD, kit, fluorescent immunoassay

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Transferrin IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Ferritin IVD, kit, fluorescent immunoassay

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Estradiol (oestradiol) (E2) IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Dengue virus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Carcinoembryonic antigen (CEA) IVD, kit, fluorescent immunoassay

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

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

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 19, 2024

Thyroid stimulating hormone (TSH) IVD, kit, rapid ICT, self-testing

Manufacturer:

PRIMA Lab SA

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 10, 2024

Total thyroxine (TT4) IVD, kit, fluorescent immunoassay

Manufacturer:

Xiamen Wiz Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 1, 2024

Bone tap, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Bone tap, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Internal spinal fixation system cable, sterile

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Lumbar interspinous decompression instrument set, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic bone screw, non-bioabsorbable, sterile

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic bone washer, non-sterile

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical implant/trial-implant/sizer holder, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical tamp, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic cerclage applier

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

HIV1/HIV2 antigen IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Orthopaedic counter-torque/rod-pushing instrument

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic prosthesis implantation positioning instrument, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic prosthesis implantation positioning instrument, single-use

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical countersink, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical flat-nosed pliers

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

MRI system application software

Manufacturer:

Quibim, S.L.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Tendon/ligament bone anchor, non-bioabsorbable

Manufacturer:

Groupe Lépine

Type:

General Medical Device

Registration Date:

Sep 24, 2024

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

Manufacturer:

bioLytical Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

SARS-CoV-2 total antibody IVD, control

Manufacturer:

bioLytical Laboratories Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Chemiluminescent immunoassay analyser IVD

Manufacturer:

NBCL B.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Surgical depth gauge, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Sternal fixation device

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Evacuated blood collection tube IVD, anticoagulant/cell preservative

Manufacturer:

Foundation Medicine, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Polymeric spinal interbody fusion cage

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Internal spinal fixation system cable tensioner

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Internal spinal fixation system cable, non-sterile

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Lumbar decompression interspinous spacer

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic bone screw, non-bioabsorbable, non-sterile

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic fixation implant alignment tool

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic implant inserter/extractor, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic implant/instrument assembling device

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical retraction system, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical mallet

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical instrument handle, torque-limiting

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

General internal orthopaedic fixation system implantation kit

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Abdominal/ENT/orthopaedic surgical probe, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Bone file/rasp, manual, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Bone matrix implant, composite

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Cannulated surgical drill bit, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

General external orthopaedic fixation system implantation kit, single-use

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

General internal orthopaedic fixation system implantation kit

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Multiple immunohaematology test IVD, control

Manufacturer:

DIAGAST

Type:

In Vitro Diagnostic Device

Registration Date:

Sep 24, 2024

Cytology scraper, single-use

Manufacturer:

Rovers Medical Devices B.V.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical instrument/endoscope cleaning utensil, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Bone curette, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Bone-screw internal spinal fixation system, non-sterile

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Orthopaedic rod reducer

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 24, 2024

Surgical implant template, reusable

Manufacturer:

Pioneer Surgical Technologies Inc.

Type:

General Medical Device

Registration Date:

Sep 23, 2024

Multi-modality clinical specimen analysis system IVD

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Jul 31, 2024

Microplate/tube/assay card incubator IVD

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Jul 31, 2024

Multiple clinical chemistry protein IVD, reagent

Manufacturer:

Nanomix Corp.

Type:

In Vitro Diagnostic Device

Registration Date:

Jul 22, 2024

Multiplex analyser IVD, point-of-care

Manufacturer:

Nanomix Corp.

Type:

In Vitro Diagnostic Device

Registration Date:

Jul 22, 2024

Coeliac disease genetic risk factor IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Blackhills Diagnostic Resources S.L.U.

Type:

In Vitro Diagnostic Device

Registration Date:

Jul 1, 2024

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

Manufacturer:

Blackhills Diagnostic Resources S.L.U.

Type:

In Vitro Diagnostic Device

Registration Date:

Jul 1, 2024

Hereditary haemochromatosis IVD, kit, nucleic acid technique (NAT)

Manufacturer:

Blackhills Diagnostic Resources S.L.U.

Type:

In Vitro Diagnostic Device

Registration Date:

Jul 1, 2024

Faecal occult blood IVD, reagent

Manufacturer:

Eurospital S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

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

Manufacturer:

Eurospital S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Thermal cycler nucleic acid amplification analyser IVD, laboratory

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Glucose monitoring system IVD, home-use

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Glucose IVD, reagent

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Fluorescent spectrophotometer IVD

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Calprotectin IVD, kit, rapid ICT, clinical

Manufacturer:

Eurospital S.p.A.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

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

Manufacturer:

Shenzhen Tisenc Medical Devices Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Cystatin C IVD, control

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

General specimen container IVD, additive/medium

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Glucose analyser IVD, home-use

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Glucose IVD, control

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Fatty acid binding protein (FABP) IVD, control

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

SARS-CoV-2 neutralizing antibody IVD, kit, fluorescent immunoassay, rapid

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

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

Manufacturer:

Guangzhou Wondfo Biotech Co., Ltd.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 11, 2024

Dengue virus antigen IVD, kit, rapid ICT, clinical

Manufacturer:

ADVY CHEMICAL PVT. LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 19, 2023

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

Manufacturer:

ADVY CHEMICAL PVT. LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 19, 2023

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

Manufacturer:

ADVY CHEMICAL PVT. LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 19, 2023

Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, rapid ICT, clinical

Manufacturer:

ADVY CHEMICAL PVT. LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 19, 2023

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

Manufacturer:

ADVY CHEMICAL PVT. LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 19, 2023

Plasmodium falciparum antigen IVD, kit, rapid ICT, clinical

Manufacturer:

ADVY CHEMICAL PVT. LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 19, 2023

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

Manufacturer:

ADVY CHEMICAL PVT. LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 19, 2023

Troponin I IVD, kit, rapid ICT, clinical

Manufacturer:

ADVY CHEMICAL PVT. LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 19, 2023

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

Manufacturer:

ADVY CHEMICAL PVT. LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 19, 2023

Radiology DICOM image processing application software

Manufacturer:

Quibim, S.L.

Type:

General Medical Device

Registration Date:

Dec 15, 2022

Self-care monitoring/reporting software

Manufacturer:

Tucuvi Care, S.L.

Type:

General Medical Device

Registration Date:

Dec 9, 2022

Nucleic acid extraction/isolation kit IVD

Manufacturer:

Omega Bio-tek

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 31, 2022

Multiple clinical chemistry analyser IVD, laboratory

Manufacturer:

FURUNO ELECTRIC CO., LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

May 16, 2022

Multiple clinical chemistry analyser IVD, laboratory

Manufacturer:

FURUNO ELECTRIC CO., LTD.

Type:

In Vitro Diagnostic Device

Registration Date:

May 16, 2022

Chemiluminescent immunoassay analyser IVD

Manufacturer:

Diatron MI Plc.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 28, 2022

Chemiluminescent immunoassay analyser IVD

Manufacturer:

Stratec Consumables GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 28, 2022

Chemiluminescent immunoassay analyser IVD

Manufacturer:

Diatron MI Plc.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 28, 2022

Chemiluminescent immunoassay analyser IVD

Manufacturer:

Stratec Consumables GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 28, 2022

Stool softener, oral

Manufacturer:

Fairpharm Vertriebs GmbH

Type:

General Medical Device

Registration Date:

Apr 11, 2022

Specimen information management system IVD

Manufacturer:

Inpeco SA

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 12, 2022

Specimen processing instrument IVD

Manufacturer:

Inpeco SA

Type:

In Vitro Diagnostic Device

Registration Date:

Jan 12, 2022

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

Manufacturer:

Genomic Health, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Dec 22, 2021

Cancer risk assessment interpretive software IVD

Manufacturer:

Genomic Health, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Dec 22, 2021

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

Manufacturer:

UgenTec N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Dec 14, 2021

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

Manufacturer:

UgenTec N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Dec 14, 2021

Dental implant holding endpiece

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Surgical screwdriver, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Dental soft-tissue coring punch, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Dental prosthesis/implant abutment screw

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Dental implantation drilling template retention pin

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Dental implantation drilling template guide-sleeve

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Dental implant suprastructure, permanent, preformed

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Dental drill bit extension

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Dental implant suprastructure, permanent, preformed

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Bone trephine

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Bone tap, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Dental osteotome

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Dental implant suprastructure, permanent, preformed

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Dental implant abutment analog, scanning

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Craniofacial bone screw, non-bioabsorbable, sterile

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Fixture/appliance dental drill bit, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Dental torque wrench

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Dental implantation depth/angle gauge, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Dental implant suprastructure, temporary, preformed, single-use

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Dental implant suprastructure, temporary, preformed, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Screw endosteal dental implant, two-piece

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Surgical instrument/implant depth limiter

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Surgical countersink, reusable

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Sliding dental precision attachment

Manufacturer:

BIOTEC s.r.l.

Type:

General Medical Device

Registration Date:

Nov 5, 2021

Evacuated blood collection tube IVD, anticoagulant/cell preservative

Manufacturer:

Foundation Medicine, Inc.

Type:

In Vitro Diagnostic Device

Registration Date:

Nov 4, 2021

SARS-CoV-2 total antibody IVD, kit, magnetic immunoassay, rapid

Manufacturer:

Blusense Diagnostics ApS

Type:

In Vitro Diagnostic Device

Registration Date:

Oct 26, 2021

Multiplex analyser IVD, point-of-care

Manufacturer:

Blusense Diagnostics ApS

Type:

In Vitro Diagnostic Device

Registration Date:

Oct 26, 2021

Faecal specimen collection kit IVD, clinical

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 10, 2021

Immunoassay instrument/analyser general performance control kit IVD

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 10, 2021

Enzyme immunoassay (EIA) analyser IVD

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 10, 2021

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

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 10, 2021

Ferritin IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 10, 2021

Enzyme immunoassay (EIA) analyser IVD

Manufacturer:

ORGENTEC Diagnostika GmbH

Type:

In Vitro Diagnostic Device

Registration Date:

Aug 10, 2021

SARS-CoV-2 antigen IVD, control

Manufacturer:

Sanwa BioTech Limited

Type:

In Vitro Diagnostic Device

Registration Date:

May 27, 2021

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

Manufacturer:

Sanwa BioTech Limited

Type:

In Vitro Diagnostic Device

Registration Date:

May 27, 2021

Femoral head prosthesis trial

Manufacturer:

Groupe Lépine

Type:

General Medical Device

Registration Date:

Apr 30, 2021

Polymer orthopaedic cement restrictor, bioabsorbable

Manufacturer:

Groupe Lépine

Type:

General Medical Device

Registration Date:

Apr 30, 2021

Orthopaedic cement dispenser

Manufacturer:

Groupe Lépine

Type:

General Medical Device

Registration Date:

Apr 30, 2021

Orthopaedic surgical procedure kit, non-medicated, single-use

Manufacturer:

Groupe Lépine

Type:

General Medical Device

Registration Date:

Apr 30, 2021

Surgical implant/trial-implant/sizer holder, reusable

Manufacturer:

Groupe Lépine

Type:

General Medical Device

Registration Date:

Apr 30, 2021

Press-fit femoral stem prosthesis

Manufacturer:

Groupe Lépine

Type:

General Medical Device

Registration Date:

Apr 30, 2021

HIV1/HIV2 antibody IVD, kit, enzyme immunoassay (EIA)

Manufacturer:

Fujirebio Europe N.V.

Type:

In Vitro Diagnostic Device

Registration Date:

Apr 13, 2021

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

Last updated: December 2025