Anti-SSB(La) Antibody Chemiluminescent Immunoassay Kit
by Maccura Biotechnology Co., Ltd. China EUDAMED
Ref IM4409258Model IM4402258 IM4403258 IM4409258 IM4407258
EMDN W0102100113
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69506174IM440258DV | Date28 Apr 2026 | StatusActive |
| European Union | CE/IVDD | Number69506174IM440258DV | Date28 Apr 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR, CE/IVDD Active
Specification
- Device Name
- Anti-SSB(La) Antibody Chemiluminescent Immunoassay Kit
- Model / Reference
- IM4402258 IM4403258 IM4409258 IM4407258, IM4409258
- Primary DI / UDI-DI
- 06950617402602, D-IM4409258KQ
- Basic UDI-DI
- 69506174IM440258DV, B-IM4409258KQ
- Direct Marketing DI
- 06950617402602
- EMDN Code
- W0102100113 Ss-b
- Device Class
- Class BClass IVD General
- Market of Registration
- SpainGermany
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 (2)
- EUDAMED e0d2a93f-5cec-4e26-9a75-e2731f1bdd24
- EUDAMED cefd0f06-4f26-4624-8253-eba9816c82ec