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Vitamin B12 Detection Kit(Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3014701Model 1×50 tests/kitRef 3014731Model 1×100 tests/kit
Identity
- Trade Name
- Vitamin B12 Detection Kit(Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Vitamin B12 Detection Kit(Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 1×50 tests/kit EUDAMED3014701 EUDAMED1×100 tests/kit EUDAMED3014731 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794523976 EUDAMED06925794523983 EUDAMED
- Basic UDI-DI
- B-06925794523976 EUDAMEDB-06925794523983 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
Yes
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 Detection Kit(Chemiluminescence Immunoassay) by Dirui Industrial 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-06925794523976 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED c26f1694-6ec6-4893-8ede-8320892b5303 61 fields · synced Jul 12, 2026
- EUDAMED df113afc-a962-469f-bf9a-a9265dedd4c3 61 fields · synced May 19, 2026