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VivaChek Fad Blood Glucose Test Strips
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref VGS02-032Model VGS02Ref VGS02-035Ref VGS02-038Ref VGS02-031Ref VGS02-034Ref VGS02-036
Identity
- Trade Name
- VivaChek Fad Blood Glucose Test Strips EUDAMED
- Device Name
- VivaChek Fad Blood Glucose Test Strips EUDAMED
- Model / Reference
- VGS02 EUDAMEDVGS02-032 EUDAMEDVGS02-035 EUDAMEDVGS02-038 EUDAMEDVGS02-031 EUDAMEDVGS02-034 EUDAMEDVGS02-036 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970221764125 EUDAMED06970221763432 EUDAMED06970221763630 EUDAMED06970221762459 EUDAMED06937339208743 EUDAMED06970221762435 EUDAMED
- Basic UDI-DI
- B-06970221764125 EUDAMEDB-06970221763432 EUDAMEDB-06970221763630 EUDAMEDB-06970221762459 EUDAMEDB-06937339208743 EUDAMEDB-06970221762435 EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Netherlands EUDAMEDPoland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
VivaChek Fad Blood Glucose Test Strips by VivaChek Biotech (Hangzhou) Co., Ltd. — Class IVD Annex II List B — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06970221764125 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000012160
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (6)
- EUDAMED 42a0df39-646b-4b46-8102-7e46ea5a39ce 61 fields · synced Oct 7, 2026
- EUDAMED fd4f0619-a6b7-42d3-9a6c-6b9a96c20742 61 fields · synced Jul 10, 2026
- EUDAMED d0161ec1-790b-4876-86ec-ee2ad1e28d2f 61 fields · synced Jul 17, 2026
- EUDAMED e66c82f5-c542-4de6-9629-29cd4806e4f2 61 fields · synced Jul 20, 2026
- EUDAMED 1b8097a3-85f7-48b4-894f-35be6cc1c789 61 fields · synced Jul 27, 2026
- EUDAMED f1761aaf-d858-4e41-b19b-f4ac055d97c9 61 fields · synced Sep 30, 2026