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VivaDiag Vitamin B12 Test Kit (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref VID128-07-011Model VID128
Identity
- Trade Name
- VivaDiag Vitamin B12 Test Kit (FIA) EUDAMEDVitamin B12 Test Kit (FIA) EUDAMED
- Device Name
- VivaDiag Vitamin B12 Test Kit (FIA) EUDAMEDVitamin B12 Test Kit (FIA) EUDAMED
- Model / Reference
- VID128 EUDAMEDVID128-07-011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937339205070 EUDAMEDD-VID128F3 EUDAMED06937339209191 EUDAMED
- Basic UDI-DI
- B-06937339205070 EUDAMEDB-VID128F3 EUDAMEDB-06937339209191 EUDAMED
- EMDN Code
- W0102070204 VITAMIN B12 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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 Vitamin B12 Test Kit (FIA) 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-06937339205070 | 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 7cac8c1f-be62-46fa-a515-33938a68b9b5 61 fields · synced Oct 6, 2026
- EUDAMED 74638bbb-82fb-4ef9-9587-b6fa02742f1b 61 fields · synced May 19, 2026
- EUDAMED f455ed29-9b71-4bdf-8230-d1eccec9b06c 61 fields · synced Jul 13, 2026