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VivaChek Biotech (Hangzhou) Co., Ltd.

China·CN-MF-000012160

Last updated June 8, 2026

Information

Country: China
Address: Building 2, No.17 Wuzhou Road, Donghu Street, Linping District , Hangzhou, Zhejiang, China
Website: vivachek.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: XIAODONG QIAN
EUDAMED SRN: CN-MF-000012160
FDA FEI Number: —
DUNS Number: —

Catalogue (425)

Page 3 of 9

Device	Model / Reference	Registries	Class	Status
HSV 1/2 IgG/IgM Combo Rapid Test	VIHV-426	EUDAMED	IVD General	Active
Testosterone Control Solution (FIA)	VIC56-05-011	EUDAMED	IVD General	Active
Rota/Adeno Ag Rapid Test	VIRA-626	EUDAMED	IVD General	Active
H. pylori Antigen Control Solution (FIA)	VIC83-01-011	EUDAMED	IVD General	Active
Ethyl Glucuronide (EtG) Rapid Test	VDET-102	EUDAMED	IVD General	Active
hMPV Rapid Test	VIMPV-702	EUDAMED	IVD General	Active
VivaChek FAD Blood Glucose Meter	VGM03-036	EUDAMED	IVD Annex II List B	Active
Rotavirus/Adenovirus Combo Rapid Test	VIRA-627	EUDAMED	IVD General	Active
Portable FIA Analyzer	VIM300H-00-01	EUDAMED	Class A	Active
Adenovirus/RSV Combo Rapid Test	VIAR-727	EUDAMED	IVD General	Active
Drugs of Abuse Rapid Test Panel	VDCO	EUDAMED	IVD General	Active
H. pylori Antigen Test Kit ( FIA)	VID83-01-011	EUDAMED	IVD General	Active
Adenovirus/RSV/Influenza A+B Combo Rapid Test	VIARI-747	EUDAMED	IVD General	Active
Multi-Drugs Rapid Test Cup	VDMC-1108	EUDAMED	IVD General	Active
Amphetamine (AMP) Rapid Test	VDAM-102	EUDAMED	IVD General	Active
Lyme IgG/IgM Rapid Test	VILY-426	EUDAMED	IVD General	Active
Nuclear Matrix Protein 22 Rapid Test	VTNMP-102	EUDAMED	IVD General	Active
HAV IgM Rapid Test	VIHAg-402	EUDAMED	IVD General	Active
CEA Rapid Test	VTCE-402	EUDAMED	IVD General	Active
Chikungunya IgG/IgM Rapid Test	VICK-426	EUDAMED	IVD General	Active
HSV Rapid Test	VIHV-502	EUDAMED	IVD General	Active
Multiplex Respiratory Antigen Rapid Test	VIRI-7117	EUDAMED	IVD General	Active
VivaChek Ino Blood Glucose Test Strips	VGS01-018	EUDAMED	IVD Annex II List B	Active
Streptococcus pneumoniae Ag Rapid Test	VISP-102	EUDAMED	IVD General	Active
VivaChek FAD Blood Glucose Meter	VGM03-035	EUDAMED	IVD Annex II List B	Active
Typhoid IgG/IgM Rapid Test	VITYb-402	EUDAMED	IVD General	Active
VivaChek Ino Blood Glucose Test Strips	VGS01-012	EUDAMED	IVD Annex II List B	Active
Malaria P.f./P.v./Pan Rapid Test	VIMP-236	EUDAMED	IVD General	Active
Leptospira IgG/IgM Rapid Test	VILP-426	EUDAMED	IVD General	Active
hCG Pregnancy Rapid Test	VHHC-U101	EUDAMED	IVD General	Active
Cardiac Combo (cTnI/CK-MB/MYO) Control Solution (FIA)	VIC15-03-011	EUDAMED	IVD General	Active
CK-MB Rapid Test	VCCK-402	EUDAMED	IVD General	Active
Campylobacter Rapid Test	VICB-602	EUDAMED	IVD General	Active
Drugs of Abuse Rapid Test Midstream	VDBZO-B303	EUDAMED	IVD General	Active
Malaria P.f./Pan Rapid Test	VIMP-221	EUDAMED	IVD General	Active
Dengue IgG/IgM Rapid Test	VIDEb-T402	EUDAMED	IVD General	Active
VivaChek Fad Blood Glucose Test Strips	VGS02-039	EUDAMED	IVD Annex II List B	Active
Clonazepam (CLO) Rapid Test	VDCLO-102	EUDAMED	IVD General	Active
Influenza A+B Rapid Test	VIFLab-702	EUDAMED	IVD General	Active
POCT Analyzer VIM2000	VIM2000-00-011	EUDAMED	Class A	Active
BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel	K261280	FDA 510(k)	Class II	Active
Syphilis Rapid Test	VISY-402	EUDAMED	IVD General	Active
Cardiac Combo (cTnI/CK-MB/MYO) Control Solution (FIA)	VIC15-03-011	EUDAMED	IVD General	Active
Multi-Drugs Rapid Test Panel 10	VDMP-1105-003	EUDAMED	IVD General	Active
Carbohydrate Antigen 15-3 Control Solution (FIA)	VIC97-06-011	EUDAMED	IVD General	Active
Influenza A+B Rapid Test	VIFLab-702	EUDAMED	IVD General	Active
VivaDiag Plus	VOM01-011	EUDAMED	Class A	Active
Beta Human Chorionic Gonadotropin Test Kit (FIA)	VID19-05-011	EUDAMED	IVD General	Active
Carbohydrate Antigen 19-9 Test Kit (FIA)	VID57-06-011	EUDAMED	IVD General	Active
Vivadiag	LS-103-2	EUDAMED	IVD General	Active

VivaChek Biotech (Hangzhou) Co., Ltd.

Information

Catalogue (425)

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