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

GeneSign Measles IgG/IgM Rapid Test Ref GS110137C01

Influenza A&B/RSV Antigen Rapid Test Ref GS110115C01

GeneSign Microalbumin Rapid Test Cassette Ref GS111005C01

GeneSign Rapid Norovirus I+II/Rota/Adeno/Astv Ag Test Ref GS110529C01

GeneSign Zika Virus IgG/IgM Rapid Test Ref GS110421C25

GeneSign One Step Heroin Test Ref GS110901D281

Troponin I/Myoglobin/CK-MB Rapid Test Ref GS110603C25

Monkeypox Virus Antigen Rapid Test Ref GS110222C01

GeneSign TB IgG/IgM Rapid Test Ref GS110126C25

GeneSign Carbapenemase Rapid Test Ref GS111006C25

GeneSign SP-10 Male Fertility Rapid Test Ref GS110321C25

GeneSign PRL FIA Ref GS121003C01

25-Oh-Vd Fia Ref GS121101C01

Novel Coronavirus (2019-nCoV) Antigen Testing Kit Ref GS110102C01

Malaria P.f Antigen Rapid Test Ref GS110411C

GeneSign Measles IgG/IgM Rapid Test Ref GS110137C25

GeneSign G6PD Test Kit Ref GS110805C25

GeneSign Rapid Norovirus I+II/Rota/Adeno/Astv Ag Test Ref GS110529C25

CRP Semi-Quantitative Rapid Test Ref GS110606C25

Ck-Mb Fia Ref GS120703C01

COVID-19/Flu A/Flu B Antigen Rapid Test Ref GS110105C01

GeneSign Nipah Virus Antigen Rapid Test Ref GS110425C01

LH Ovulation Rapid Test Ref GS110304C01

Vibrio Cholerae O1/O139 Antigen Rapid Test Ref GS110515C25

NT-proBNP FIA Ref GS120706C25

GeneSign FSH FIA Ref GS121001C25

GeneSign SP-10 Male Fertility Rapid Test Ref GS110321C01

GeneSign One Step COC Test Ref GS110901D051

GeneSign HSV-I IgM/IgG Rapid Test Ref GS110316C25

IgE FIA Ref GS121201C25

GeneSign JEV IgG/IgM Rapid Test Ref GS110430C25

GeneSign TT3 FIA Ref GS120903C01

Malaria Pf/Pan Antigen Rapid Test Ref GS110403C01

COVD-19/FLU/RSV Conbo Rapid Test Ref GS110116C01

Influenza A/B Antigen Rapid Test Ref GS110106C01

GeneSign Zika Virus IgG/IgM Rapid Test Ref GS110421C01

Salmonella Typhi/ Paratyphi Antigen Rapid Test Ref GS110507C01

GeneSign One Step COC Test Ref GS110901D0525

H. Pylori Antigen Rapid Test Ref GS110503C01

GeneSign Chikungunya IgG/IgM Rapid Test Ref GS110418C01

GeneSign BNP FIA Ref GS120709C01

GeneSign cTnT FIA Ref GS120708C01

Respiratory Adenovirus Antigen Rapid Test Ref GS110110C01

fFN Rapid Test Ref GS110318C01

Respiratory Combo Antigen Rapid Test Ref GS110112C01

Myo FIA Ref GS120704C01

GeneSign LH FIA Ref GS121002C25

GeneSign JEV IgG/IgM Rapid Test Ref GS110430C01

GeneSign SFTSV Antigen Rapid Test Ref GS110431C25

GeneSign One Step COD Test Ref GS110901D2925

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