Automated Digital Cell Morphology Analyzer
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref MC-82Model MC-80、MC-82
EMDN W02029099
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69449040AB3000005ZK | Date3 Aug 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- MC-80、MC-82, MC-82
- Primary DI / UDI-DI
- 06936415988418
- Basic UDI-DI
- 69449040AB3000005ZK
- EMDN Code
- W02029099 Various hematology / histology / cytology instruments - other
- Device Class
- Class B
- 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 (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No
Sources (1)
- EUDAMED 7b377247-0d3e-40e2-95f7-4406e6888527