D-Dimer & FDP Control
by Maccura Biotechnology Co., Ltd. China EUDAMED
Ref EBL2192006, EBL2192005, EBL2101008, EBL2191008, EBL2104008, EBL2191007, EBL2105008
EMDN W0103020799
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-EBL2192006AG | Date22 May 2022 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- D-Dimer & FDP ControlD-Dimer
- Model / Reference
- EBL2192006, EBL2192005, EBL2101008, EBL2191008, EBL2104008, EBL2191007, EBL2105008
- Primary DI / UDI-DI
- D-EBL2192006AG, D-EBL2192005AE, D-EBL21010087A, D-EBL2191008AD, D-EBL21040087X, D-EBL2191007AB, D-EBL210500886
- Basic UDI-DI
- B-EBL2192006AG, B-EBL2192005AE, B-EBL21010087A, B-EBL2191008AD, B-EBL21040087X, B-EBL2191007AB, B-EBL210500886
- EMDN Code
- W0103020799, W0103020503
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014618
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Maccura Biotechnology Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (6)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (7)
- EUDAMED 9b9df7b1-072c-4e2e-b72b-7f5d15ec547e
- EUDAMED D-EBL2192005AE|B-EBL2192005AE
- EUDAMED D-EBL21010087A|B-EBL21010087A
- EUDAMED D-EBL2191008AD|B-EBL2191008AD
- EUDAMED D-EBL21040087X|B-EBL21040087X
- EUDAMED D-EBL2191007AB|B-EBL2191007AB
- EUDAMED D-EBL210500886|B-EBL210500886