Identity
- Trade Name
- FOB Rapid Test EUDAMED
- Device Name
- FOB Rapid Test EUDAMED
- Model / Reference
- VTFO EUDAMEDVTFO-U602 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970221769106 EUDAMED06937339203441 EUDAMED06937339210166 EUDAMED
- Basic UDI-DI
- B-06970221769106 EUDAMEDB-06937339203441 EUDAMEDB-06937339210166 EUDAMED
- EMDN Code
- W0102160299 TUMOUR MARKER RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
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
FOB Rapid Test 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-06970221769106 | 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 (3)
- EUDAMED e4953a52-8b55-4ab4-a4b2-0df2e8c28a91 61 fields · synced Oct 6, 2026
- EUDAMED bfa30146-f7aa-4738-9d6b-e0527830cb6e 61 fields · synced May 18, 2026
- EUDAMED 76c84dc4-a986-4d07-9661-a98e4ec9ecc4 61 fields · synced Oct 6, 2026