Identity
- Trade Name
- Vivadiag Plus EUDAMED
- Device Name
- Hemoglobin Test Strips EUDAMED
- Model / Reference
- VOS01 EUDAMEDVOS01-012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VOS01-0129B EUDAMED
- Basic UDI-DI
- B-VOS01-0129B EUDAMED
- EMDN Code
- W0103010201 HAEMOGLOBIN DETERMINATIONS (TOTAL HB) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Vivadiag Plus by VivaChek Biotech (Hangzhou) Co., Ltd. — Class IVD General — 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-VOS01-0129B | Class IVD General | 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 bae0c683-114b-4af7-b183-54e4e4a4de89 61 fields · synced Jun 18, 2026