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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
—
Phone
—
PRRC Contact
XIAODONG QIAN
EUDAMED SRN
CN-MF-000012160
FDA FEI Number
—
DUNS Number
—

Catalogue (425)

Page 4 of 9
DeviceModel / ReferenceRegistriesClassStatus
Myoglobin Test Kit (FIA) VID12-03-011
EUDAMED
IVD GeneralActive
Ferritin Test Kit (FIA) VID28-07-011
EUDAMED
IVD GeneralActive
Progesterone Test Kit (FIA) VID55-05-011
EUDAMED
IVD GeneralActive
Multi-Drugs Rapid Test 1-Step Cup VDMC-1108-002
EUDAMED
IVD GeneralActive
Human Growth Hormone Test Kit VID73- 05-011
EUDAMED
IVD GeneralActive
Tuberculosis IgG/IgM Rapid Test VITB-402
EUDAMED
IVD GeneralActive
Parathyroid Hormone Test Kit VID74- 05-011
EUDAMED
IVD GeneralActive
Thyroxine Test Kit (FIA) VID22-05-011
EUDAMED
IVD GeneralActive
Opiate(OPI) Rapid Test VDOP-101
EUDAMED
IVD GeneralActive
Heart Fatty Acid Binding Protein Test Kit (FIA) VID13-03-011
EUDAMED
IVD GeneralActive
VivaChek Eco Control Solution VGC01-021
EUDAMED
IVD Annex II List BActive
Dengue IgG/IgM Rapid Test VIDEb-402
EUDAMED
IVD GeneralActive
Total Immunoglobulin E Control Solution (FIA) VIC61-10-011
EUDAMED
IVD GeneralActive
Amphetamine(AMP) Rapid Test VDAM-102
EUDAMED
IVD GeneralActive
VivaDiag Heart Fatty Acid Binding Protein Control Solution (FIA) VIC13-03-011
EUDAMED
IVD GeneralActive
VivaDiag™ Monkeypox Virus Ag Rapid Test VIMV-702
EUDAMED
IVD GeneralActive
VivaDiag 25-Hydroxyvitamin D3 (25-OH-D3) Control Solution (FIA) VIC29-07-011
EUDAMED
IVD GeneralActive
iGFBP-1 Rapid Test VHIG-702
EUDAMED
IVD GeneralActive
Cytokeratin 19 Fragment (CYFRA21-1) Control Solution (FIA) VIC117-06-011
EUDAMED
IVD GeneralActive
VivaDiag Synthetic Marijuana K3 Test Kit (FIA) VID130-09-011
EUDAMED
IVD GeneralActive
Thyroid Stimulating Hormone Test Kit (FIA) VID20-05-011
EUDAMED
IVD GeneralActive
Carbohydrate Antigen 125 Test Kit (FIA) VID100-06-011
EUDAMED
IVD GeneralActive
SARS-CoV-2/Flu A/FIu B Ag VLD01-03-13
EUDAMED
IVD GeneralActive
Neutropil Gelatinase-associated Lipocalin Test Kit (FIA) VID08-02-011
EUDAMED
IVD GeneralActive
VivaDiag Micro Albuminuria Control Solution (FIA) VIC06-02-011
EUDAMED
IVD GeneralActive
VivaDiag Herpes Simplex Virus Type 1 IgM Test Kit (FIA) VID134-01-011
EUDAMED
IVD GeneralActive
Vivadiag Plus VOS01-012
EUDAMED
IVD GeneralActive
Serum Amyloid A Protein Test Kit (FIA) VID04-01-011
EUDAMED
IVD GeneralActive
VivaDiag Herpes Simplex Virus Type 1 IgG Test Kit (FIA) VID133-01-011
EUDAMED
IVD GeneralActive
Benzodiazepine(BZO) Rapid Test VDBZ-102
EUDAMED
IVD GeneralActive
Cardiac Combo (cTnI/CK-MB) Test Kit (FIA) VID45-03-011
EUDAMED
IVD GeneralActive
Bone Markers Control Solution (FIA) VIC152-12-011
EUDAMED
IVD GeneralActive
BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx K233062
FDA 510(k)
Class IIActive
BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Panel 20; BioSieve™ Dx Marijuana Test Panel 50 K231978
FDA 510(k)
Class IIActive
Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx K222667
FDA 510(k)
Class IIActive
VivaChek Link Plus Blood Glucose Monitoring System K233058
FDA 510(k)
Class IIActive
Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup K252554
FDA 510(k)
Class IIActive
BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader K241869
FDA 510(k)
Class IIActive
VivaChek Blood Glucose and B-Ketone Monitoring System K192957
FDA 510(k)
Class IActive
VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System K222126
FDA 510(k)
Class IIActive
BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader K240124
FDA 510(k)
Class IIActive
25-Hydroxyvitamin D3 (25-OH-D3) Test Kit (FIA) VID29-07-011
EUDAMED
IVD GeneralActive
Pregnancy-Associated Plasma Protein A Test Kit (FIA) VID143-05-011
EUDAMED
IVD GeneralActive
Vivadiag LA-137-1
EUDAMED
IVD GeneralActive
Synthetic Cannabinoid(K2) Rapid Test VDK2-102
EUDAMED
IVD GeneralActive
VivaDiag Triiodothyronine Control Solution (FIA) VIC21-05-011
EUDAMED
IVD GeneralActive
Creatine Kinase-MB Test Kit (FIA) VID10-03-011
EUDAMED
IVD GeneralActive
Des-Gamma-Carboxy Prothrombin Test Kit (FIA) VID136-06-011
EUDAMED
IVD GeneralActive
Vivadiag LS-133-2
EUDAMED
IVD GeneralActive
VivaGuard V20 Blood Glucose Test Strips VGS01-688
EUDAMED
IVD Annex II List BActive

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