Manufacturer

Genobio Pharmaceutical

ChinaLegal entities : Genobio Pharmaceutical Co., Ltd.

First countries of placing on the market declared in EUDAMED : Germany, Netherlands, Spain

EU representative : Caretechion GmbH (Germany)

14 categories, 32 models including 32 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Aspergillus	W0105060301	Aspergillus Galactomanan ELISA Detection Kit98/79 Aspergillus Galactomannan Detection K-Set (Lateral Flow Assay)98/79 Aspergillus Galactomannan Detection Kit (CLIA)98/79 Aspergillus IgG Antibody Detection K-Set(Lateral Flow Assay)98/79 Aspergillus IgG Antibody Detection Kit (CLIA)98/79 1 other Aspergillus IgM Antibody Detection K-Set(CLIA)98/79	– 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	Full-Automatic Chemiluminescence Immunoassay System Fully Automatic Kinetic Tube Reader Immunochromatography Analyzer	A IVDR	EUDAMED record Report an error
Bacteriology immunoassay - other	W0105011799	Bacterial Endotoxin Detection Kit (CLIA)98/79 Carbapenem-resistant K.N.I.V.O. Detection K-Set (Lateral Flow Assay)98/79 MCR Enzyme Detection K-Set (Colloidal Gold Immunochromatography)98/79	– 98/79	EUDAMED record Report an error
Candida albicans	W0105060302	Candida IgG Antibody Detection Kit (CLIA)98/79 Candida Mannan Detection Kit (CLIA)98/79 Candida Mannan IgM Antibody Detection K-Set(CLIA) CMCLIA-0198/79	– 98/79	EUDAMED record Report an error
Candida albicans - NA reagents	W0105060402	Candida auris Molecular Detection Kit (Real-time PCR) FCUPCR-2598/79 Candida auris Molecular Detection Kit (Real-time PCR) FCUPCR-5098/79 Candida Molecular Detection Kit (Real-time PCR)2 refs98/79	– 98/79	EUDAMED record Report an error
Mycology NA reagents - other	W0105060499	Aspergillus, Cryptococcus, Candida Albicans Molecular Detection Kit (Real-time PCR) FPCR-5098/79 Talaromyces marneffei Molecular Detection Kit (Real-time PCR) FTMPCR-2598/79 Talaromyces marneffei Molecular Detection Kit (Real-time PCR) FTMPCR-5098/79	– 98/79	EUDAMED record Report an error
Cryptococcus	W0105060303	Cryptococcal Capsular Polysaccharide Detection K-Set (Lateral Flow Assay)2 refs98/79 Cryptococcal Capsular Polysaccharide Detection Kit (CLIA)98/79	– 98/79	EUDAMED record Report an error
Cryptococcus - NA reagents	W0105060403	Cryptococcus Molecular Detection Kit (Real-time PCR) FCPCR-2598/79 Cryptococcus Molecular Detection Kit (Real-time PCR) FCPCR-5098/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Influenza A&B Antigen Rapid Test (Colloidal Gold) VILFA-0198/79 Influenza A&B Antigen Rapid Test (Colloidal Gold) VILFA-2098/79	– 98/79	EUDAMED record Report an error
Aspergillus - NA reagents	W0105060401	Aspergillus Molecular Detection Kit (Real-time PCR)2 refs98/79	– 98/79	EUDAMED record Report an error
Beta-d-glucan (pan-fungal markers)	W0105060304	Fungus (1-3)-β-D-Glucan Detection Kit (CLIA)98/79	– 98/79	EUDAMED record Report an error
Monkeypox virus / mpox - NA reagent	W0105040532	Monkeypox Virus Molecular Detection Kit (Real-time PCR)2 refs98/79	– 98/79	EUDAMED record Report an error
Mycology immunoassays - other	W0105060399	Mucorales Molecular Detection Kit (Real-time PCR)2 refs98/79	– 98/79	EUDAMED record Report an error
Pneumocystis - NA reagents	W0105060405	Pneumocystis Molecular Detection Kit (Real-time PCR)2 refs98/79	– 98/79	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.