← Back to catalogue
Vitamin B12 (VB12) Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 25 Tests/KitRef 50 Tests/Kit
Identity
- Trade Name
- Vitamin B12 (VB12) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Device Name
- Vitamin B12 (VB12) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- 25 Tests/Kit EUDAMED50 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986815139 EUDAMED06974986815146 EUDAMED
- Basic UDI-DI
- B-06974986815139 EUDAMEDB-06974986815146 EUDAMED
- EMDN Code
- W0102070204 VITAMIN B12 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Vitamin B12 (VB12) Assay Kit (Chemiluminescent Immunoassay) by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06974986815139 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wuhan Life Origin Biotech Joint Stock Co., Ltd.
- EUDAMED SRN
- CN-MF-000027340
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED f09b0d20-5d79-41b2-bc61-fa399c3c2002 61 fields · synced Oct 6, 2026
- EUDAMED fd651f52-e895-457d-b65b-4ee45eff8837 61 fields · synced May 17, 2026