Prolactin (CLIA)
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref 105-004251-00Model 105-004224-00、105-004251-00、105-004293-00 EMDN W0102050108
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040004H-PRL*******ED | Date12 Sep 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Prolactin (CLIA)、Prolactin Calibrators
- Model / Reference
- 105-004224-00、105-004251-00、105-004293-00, 105-004251-00
- Primary DI / UDI-DI
- 06944904047997
- Basic UDI-DI
- 69449040004H-PRL*******ED
- EMDN Code
- W0102050108 Prolactin
- 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
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 1656a2e9-5ef6-4bfc-828d-e6a98f7b1922