Identity
- Trade Name
- Vivadiag EUDAMED
- Model / Reference
- LS-103 EUDAMEDLS-123-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975519630397 EUDAMED
- Basic UDI-DI
- B-06975519630397 EUDAMED
- EMDN Code
- W0101060103 HDL TEST STRIPS 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 by VivaChek Biotech (Hangzhou) Co., Ltd. — Class IVD General — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06975519630397 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000012160
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED de1398b1-c68e-472e-a15b-237788b0e882 61 fields · synced Oct 6, 2026