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VivaChek FAD Blood Glucose Meter
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref VGM03-034Model VGM03
Identity
- Trade Name
- VivaChek FAD Blood Glucose Meter EUDAMED
- Device Name
- VivaChek FAD Blood Glucose Meter EUDAMED
- Model / Reference
- VGM03 EUDAMEDVGM03-034 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970221763982 EUDAMED
- Basic UDI-DI
- B-06970221763982 EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
VivaChek FAD Blood Glucose Meter by VivaChek Biotech (Hangzhou) Co., Ltd. — Class IVD Annex II List B — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06970221763982 | 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 (1)
- EUDAMED dd1b6970-d709-4283-bba7-8f720f0f3c57 61 fields · synced Jul 16, 2026