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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 (411)

Page 1 of 9

Device	Model / Reference	Registries	Class	Status
Dengue IgM/IgG Control Solution (FIA)	VIC87-01-011	EUDAMED	IVD General	Active
Procalcitonin Rapid Test	VIPR-402	EUDAMED	IVD General	Active
AFP Rapid Test	VTAF-402	EUDAMED	IVD General	Active
Cardiac Troponin I (cTnI) Rapid Test	VCTI-402	EUDAMED	IVD General	Active
Strep B Rapid Test	VISB-702	EUDAMED	IVD General	Active
Syphilis Control Solution (FIA)	VIC188-01-011	EUDAMED	IVD General	Active
Alcohol (ALC) Rapid Test	VDAL-101	EUDAMED	IVD General	Active
hLH Ovulation Rapid Test Midstream	VHLH-103H	EUDAMED	IVD General	Active
VivaChek FAD Blood Glucose Meter	VGM03-033	EUDAMED	IVD Annex II List B	Active
Micro-Albumin Semi-Quantitative Rapid Test	VNMBS-102	EUDAMED	IVD General	Active
Hemoglobin Testing System	VOM01-013	EUDAMED	IVD General	Active
Albumin/Creatinine Ratio Control Solution (FIA)	VIC222-02-011	EUDAMED	IVD General	Active
Hemoglobin Testing System	VOM01-011	EUDAMED	IVD General	Active
VivaChek Ino Blood Glucose Test Strips	VGS01-013	EUDAMED	IVD Annex II List B	Active
C-reactive protein (CRP) Rapid Test	VICR-402	EUDAMED	IVD General	Active
Enterovirus Rapid Test	VIEN-602	EUDAMED	IVD General	Active
AB-Pinaca (ABP) Rapid Test	VDABP-102	EUDAMED	IVD General	Active
Dengue NS1 Ag Control Solution (FIA)	VIC88-01-011	EUDAMED	IVD General	Active
Giardia Rapid Test	VIGI-602	EUDAMED	IVD General	Active
Typhoid Ag Rapid Test	VITYg-402	EUDAMED	IVD General	Active
VivaChek Ino Blood Glucose Test Strips	VGS01-015	EUDAMED	IVD Annex II List B	Active
Pro SARS-CoV-2 Ag Rapid Test	VCD16-01	EUDAMED	IVD General	Active
Tuberculosis (TB) Rapid Test	VITB-402	EUDAMED	IVD General	Active
H. pylori Antibody Test Kit (FIA)	VID82-01-011	EUDAMED	IVD General	Active
Norovirus GI/GII Rapid Test	VINO-626	EUDAMED	IVD General	Active
Mycoplasma pneumoniae IgM Rapid Test	VIMPb-402	EUDAMED	IVD General	Active
hLH Ovulation Rapid Test	VHLH-A102	EUDAMED	IVD General	Active
Max BT Blood Glucose Monitoring System	VGM05-112	EUDAMED	IVD Annex II List B	Active
VivaChek FAD Blood Glucose Meter	VGM03-034	EUDAMED	IVD Annex II List B	Active
VivaChek Ino Blood Glucose Test Strips	VGS01-016	EUDAMED	IVD Annex II List B	Active
Norovirus/Rotavirus/Adenovirus Combo Rapid Test	VINRA-647	EUDAMED	IVD General	Active
MxA/CRP Test Kit (FIA)	VID221-01-011	EUDAMED	IVD General	Active
C-peptide Test Kit (FIA)	VID17-04-011	EUDAMED	IVD General	Active
Zika IgG/IgM/NS1 Combo Rapid Test	VIZK-402	EUDAMED	IVD General	Active
High Sensitivity Cardiac Troponin I Control Solution (FIA)	VIC113-03-011	EUDAMED	IVD General	Active
Multiplex Respiratory Antigen Rapid Test	VIRI-787	EUDAMED	IVD General	Active
D-Dimer Rapid Test	VCDI-402	EUDAMED	IVD General	Active
Cardiac Combo (cTnI/NT-proBNP) Control Solution (FIA)	VIC215-03-011	EUDAMED	IVD General	Active
VivaChek Ino Blood Glucose Meter	VGM01-016	EUDAMED	IVD Annex II List B	Active
Cardiac Combo (cTnI/NT-proBNP) Test Kit (FIA)	VID215-03-011	EUDAMED	IVD General	Active
VivaChek Ino Blood Glucose Meter	VGM01-014	EUDAMED	IVD Annex II List B	Active
Follicle Stimulating Hormone Control Solution (FIA)	VIC31-05-011	EUDAMED	IVD General	Active
Multiplex Respiratory Antigen Rapid Test	VIRI-7107	EUDAMED	IVD General	Active
EV71 IgM Rapid Test	VIENm-402	EUDAMED	IVD General	Active
Strep A Control	VIC107-01-011	EUDAMED	IVD General	Active
Rotavirus Control Solution (FIA)	VIC123-01-011	EUDAMED	IVD General	Active
Syphilis Test Kit (FIA)	VID188-01-011	EUDAMED	IVD General	Active
Norovirus Control Solution (FIA)	VIC178-01-011	EUDAMED	IVD General	Active
hCG Pregnancy Rapid Test Midstream	VHHC-103H	EUDAMED	IVD General	Active
VivaChek Ino Blood Glucose Test Strips	VGS01-014	EUDAMED	IVD Annex II List B	Active

VivaChek Biotech (Hangzhou) Co., Ltd.

Information

Catalogue (411)

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