GeneSign Biotech (Xiamen)Co., Ltd.

Active in EUDAMED

Chinafrom SRN EUDAMED SRN CN-MF-000044463

Devices: 227
Registrations: EUDAMED

What GeneSign Biotech (Xiamen)Co., Ltd. makes

GeneSign Biotech (Xiamen) produces in vitro diagnostic (IVD) tests for rapid antigen detection and immunoassay analysis, including point-of-care devices for infectious diseases, cardiac markers, and allergens. Their portfolio includes tests for respiratory pathogens (e.g., COVID-19, RSV, adenovirus), malaria, vaginal infections, and inflammatory biomarkers like CRP and PCT. Fluorescence immunoassays (FIA) cover cardiac troponin, vitamin B12, and IgE levels, while rapid lateral-flow tests enable on-site screening for multiple targets simultaneously.

All listed devices fall under the EU’s IVD General classification and are registered in the EUDAMED database. The manufacturer is based in China and adheres to relevant regulatory requirements for in vitro diagnostics in the European market.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue227

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Company details

EUDAMED SRN: CN-MF-000044463
EUDAMED status: Active
EUDAMED registered name: GeneSign Biotech (Xiamen)Co., Ltd.
Registered address: Unit 03, 8th Floor, Building B14, Xiamen Biomedical, Industrial Park, 2076 Wengjiao West Road, Haicang District, 361000, Xiamen, China
Email: [email protected]
PRRC contact: Yanshuai Wang(public in EUDAMED)

What GeneSign Biotech (Xiamen)Co., Ltd. makes

Catalogue227

COVID-19/Influenza A&B/ADV Antigen Rapid Test Ref GS110133C01

Vibrio Cholerae O1 Antigen Rapid Test Ref GS110513C01

One Step Multi-Drug Screening Test Ref GS110901C01

25-Oh-Vd Fia Ref GS121101C25

GeneSign Dengue NS1/ZIKA/CHIKV Antigen Rapid Test Ref GS110422C01

Novel Coronavirus (COVID-19) Neutralizing Antibody Testing Kit Ref GS110103C01

GeneSign cTnT FIA Ref GS120708C25

GeneSign Nipah Virus Antigen Rapid Test Ref GS110425C25

GeneSign AMH FIA Ref GS121005C01

GeneSign Zika NS1 Antigen Rapid Test Ref GS110413C01

Pct Fia Ref GS120602C01

Adenovirus Antigen Rapid Test Ref GS110505C25

Anti-H. Pylori Rapid Test Ref GS110501C25

Rota/Adeno Antigen Rapid Test Ref GS110506C25

CRP/hS-CRP FIA Ref GS120601C01

COVD-19/FLU/RSV Conbo Rapid Test Ref GS110116C25

PCT Rapid Test Ref GS110610C01

cTnI/CK-MB/Myo FIA Ref GS120705C25

Respiratory Combo Antigen Rapid Test Ref GS110112C25

IgE FIA Ref GS121201C01

CRP Semi-Quantitative Rapid Test Ref GS110606C01

Malaria Pf/Pv Antigen Rapid Test Ref GS110401C25

RSV Antigen Rapid Test Ref GS110118C25

Rapid Vaginal Infection Combo Test (CA/TV/GV) Ref GS110242C25

Vitamin B12 FIA Ref GS121103C25

Strep A Antigen Rapid Test Ref GS110129C25

Rapid Semi-Quantitative HCG Urine Pregnancy Test Ref GS110315C25

HbA1C FIA Ref GS121102C01

Influenza A/B Antigen Rapid Test Ref GS110106C25

CA16 IgM Rapid Test Ref GS110524C01

fFN Rapid Test Ref GS110318C25

Typhoid IgG/IgM Rapid Test Ref GS110517C25

Novel Coronavirus (2019-nCoV) Antigen Testing Kit Ref GS110102C25

Monkeypox Virus Antigen Rapid Test Ref GS110222C25

Vibrio Cholerae O1 Antigen Rapid Test Ref GS110513C25

Syphilis Rapid Test Ref GS110205C25

Dengue IgM/IgG Rapid Test Ref GS110407C25

HPV 16/18 E7 Antigen Rapid Test Ref GS110709C25

Troponin I Rapid Test Ref GS110601C25

Dengue NS1 Ag/Ab Combo Rapid Test Ref GS110409C25

Neisseria Gonorrhoeae Antigen Rapid Test Ref GS110211C25

HPV Antigen Rapid Test Ref GS110702C25

FOB Rapid Test Ref GS110701C01

HPV L1/E7 Antigen Rapid Test Ref GS110708C25

Rotavirus Antigen Rapid Test Ref GS110504C01

Rapid Urine Alcohol Test Ref GS110901D25

LH Ovulation Rapid Test Ref GS110304C25

FT3 Fia Ref GS120902C01

Vibrio Cholerae O139 Antigen Rapid Test Ref GS110514C25

cTnI FIA Ref GS120702C25

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