Adenosine Deaminase (ADA) Calibrator
by Maccura Biotechnology Co., Ltd. China EUDAMED
Ref ECH0181206
EMDN W0101050399
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-ECH01812067H | Date22 May 2022 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- Adenosine Deaminase (ADA) Calibrator
- Model / Reference
- ECH0181206
- Primary DI / UDI-DI
- D-ECH01812067H
- Basic UDI-DI
- B-ECH01812067H
- EMDN Code
- W0101050399 Calibrators and standards (clinical chemistry) - other
- 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 (7)
- Sterile: No
- Human Tissues: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 901c60cc-1076-49f4-a689-54e6329d48ee