Anti-gp210 Antibody Chemiluminescent Immunoassay Kit
by Maccura Biotechnology Co., Ltd. China EUDAMED
Ref IM4410471Model IM4410471 IM4411471 IM4414471 IM4415471
EMDN W0102100799
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69506174IM441471E6 | Date5 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Anti-gp210 Antibody Chemiluminescent Immunoassay Kit
- Model / Reference
- IM4410471 IM4411471 IM4414471 IM4415471, IM4410471
- Primary DI / UDI-DI
- 06950617403586, 06950617403593, 06950617403562, D-IM4410471J6, 06950617403579
- Basic UDI-DI
- 69506174IM441471E6, B-IM4410471J6
- Direct Marketing DI
- 06950617403586069506174035930695061740356206950617403579
- EMDN Code
- W0102100799, W0102109099
- 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 (5)
- EUDAMED b4c72142-546c-4501-81f8-816b57341642
- EUDAMED 06950617403593|69506174IM441471E6
- EUDAMED 06950617403562|69506174IM441471E6
- EUDAMED D-IM4410471J6|B-IM4410471J6
- EUDAMED 06950617403579|69506174IM441471E6