ProGRP(CLIA)
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref 105-010084-00Model 105-010084-00、105-010094-00、105-010134-00、105-010145-00、105-010155-00、105-010150-00、105-010160-00
EMDN W0102030121
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040004V-ProGRP****FH | Date19 Sep 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- ProGRP（CLIA）、ProGRP Calibrators、ProGRP Control
- Model / Reference
- 105-010084-00、105-010094-00、105-010134-00、105-010145-00、105-010155-00、105-010150-00、105-010160-00, 105-010084-00
- Primary DI / UDI-DI
- 06936415908058
- Basic UDI-DI
- 69449040004V-ProGRP****FH
- EMDN Code
- W0102030121 Pro-gastrin-releasing peptide
- 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 (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED a4a1e0f9-be4e-43cf-9253-aee8f86d5f95