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25-OH Vitamin D Chemiluminescent Immunoassay Kit
EUDAMEDClass B (EU MDR)
Ref EIM4412048Model EIM4401048 EIM4402048 EIM4406048 EIM4407048 EIM4412048 EIM4413048
Identity
- Device Name
- 25-OH Vitamin D Chemiluminescent Immunoassay Kit EUDAMED
- Model / Reference
- EIM4401048 EIM4402048 EIM4406048 EIM4407048 EIM4412048 EIM4413048 EUDAMEDEIM4412048 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950617445036 EUDAMED
- Basic UDI-DI
- 69506174IM440048DG EUDAMED
- Direct Marketing DI
- 06950617445036 EUDAMED
- EMDN Code
- W0102060309 25-HYDROXYVITAMIN D EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Spain 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
25-OH Vitamin D Chemiluminescent Immunoassay Kit by Maccura Biotechnology 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 | 69506174IM440048DG | Class B | Active |
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Manufacturer
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014618
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 3f8b105d-9b9e-4b2b-83cb-ce63e44454e0 61 fields · synced Jun 14, 2026