Creatine Kinase-MB Kit (IFCC Method)
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref 105-004616-00, 105-004601-00Model 105-004616-00、105-000870-00、105-004601-00、105-001132-00 EMDN W01010114
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number694490400045CK-MB******U8 | Date19 Sep 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Creatine Kinase-MB Kit (IFCC Method)、CK-MB Calibrator
- Model / Reference
- 105-004616-00、105-000870-00、105-004601-00、105-001132-00, 105-004616-00, 105-004601-00
- Primary DI / UDI-DI
- 06944904053479, 06944904050799
- Basic UDI-DI
- 694490400045CK-MB******U8
- EMDN Code
- W01010114 Creatine kinase - mb activity (cc)
- Device Class
- Class C
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014156
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties & raw data
Show properties, registry sources and raw records
Other properties (6)
- Sterile: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (2)
- EUDAMED 66419ccb-96e6-4e9d-87e2-f29bffff40ff
- EUDAMED 06944904050799|694490400045CK-MB******U8