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Vitamin B12 test (Chemiluminescence Immunoassay)
EUDAMEDClass B (EU MDR)
Ref HGCL66Model Please see the IFU
Identity
- Trade Name
- Vitamin B12 test (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Vitamin B12 test (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- Please see the IFU EUDAMEDHGCL66 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936700406665 EUDAMED
- Basic UDI-DI
- 697029753300KZ EUDAMED
- EMDN Code
- W0102070204 VITAMIN B12 EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany 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
New Device
No
EUDAMED
Vitamin B12 test (Chemiluminescence Immunoassay) by Beijing Hotgen Biotech Co., Ltd. — Class B — IVDR — 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 | 697029753300KZ | Class B | Active |
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Manufacturer
- Manufacturer
- Beijing Hotgen Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000015566
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 4452ec5e-b9c2-4b8b-930f-6ce54f610580 61 fields · synced Jun 18, 2026