VB12 Chemiluminescent Binding Assay Kit
by Maccura Biotechnology Co., Ltd. China EUDAMED
Ref IM4402212, IM4403212Model IM4402212 EIM4406212 IM4403212 EIM4407212 EMDN W0102070204
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69506174IM440212D5 | Date30 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- VB12 Chemiluminescent Binding Assay Kit
- Model / Reference
- IM4402212 EIM4406212 IM4403212 EIM4407212, IM4402212, IM4403212
- Primary DI / UDI-DI
- 06950617401766, 06950617401773, D-IM4402212HF, D-IM4403212HN
- Basic UDI-DI
- 69506174IM440212D5, B-IM4402212HF, B-IM4403212HN
- Direct Marketing DI
- 0695061740176606950617401773
- EMDN Code
- W0102070204 Vitamin b12
- Device Class
- Class BClass IVD General
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000014618
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Maccura Biotechnology Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (4)
- EUDAMED a8b1b583-b9a4-4c88-ba20-efe2ad748197
- EUDAMED 06950617401773|69506174IM440212D5
- EUDAMED D-IM4402212HF|B-IM4402212HF
- EUDAMED D-IM4403212HN|B-IM4403212HN