PCT Calibrators
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref 105-010219-00Model 105-010703-00、105-010730-00、105-010219-00、105-010228-00、105-010248-00、105-010238-00、 105-010258-00
EMDN W0102069013
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040004S-PCT*******M3 | Date21 Sep 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Procalcitonin(CLIA)、PCT Calibrators、PCT Control
- Model / Reference
- 105-010703-00、105-010730-00、105-010219-00、105-010228-00、105-010248-00、105-010238-00、 105-010258-00, 105-010219-00
- Primary DI / UDI-DI
- 06936415900632
- Basic UDI-DI
- 69449040004S-PCT*******M3
- EMDN Code
- W0102069013 Procalcitonin
- 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 (7)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 6e674c68-9cde-4727-a27d-2ce36f51f16b