RF-IgA Chemiluminescent Immunoassay Kit
by Maccura Biotechnology Co., Ltd. China EUDAMED
Ref IM4407271Model IM4402271 IM4403271 IM4406271 IM4407271 IM4410271 IM4411271 IM4414271 IM4415271 EMDN W01021199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | Number69506174IM440271DM | Date29 Apr 2026 | StatusActive |
| European Union | CE/IVDR | Number69506174IM440271DM | Date29 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD, CE/IVDR Active
Specification
- Device Name
- RF-IgA Chemiluminescent Immunoassay Kit
- Model / Reference
- IM4402271 IM4403271 IM4406271 IM4407271 IM4410271 IM4411271 IM4414271 IM4415271, IM4407271
- Primary DI / UDI-DI
- 06950617433767, D-IM4407271K2
- Basic UDI-DI
- 69506174IM440271DM, B-IM4407271K2
- Direct Marketing DI
- 06950617433767
- EMDN Code
- W01021199, W01021110
- 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
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (2)
- EUDAMED 69eb839c-3c69-4abb-a77a-44d9433a2bba
- EUDAMED D-IM4407271K2|B-IM4407271K2