Auto Hematology Analyzer
by Rayto Life and Analytical Sciences Co., Ltd. China EUDAMED
Ref RT-7600
EMDN W0202010201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberB-RT-7600SV | Date29 May 2026 | StatusActive |
| European Union | CE/IVDD | NumberB-RT-7600SV | Date29 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR, CE/IVDD Active
Specification
- Model / Reference
- RT-7600
- Primary DI / UDI-DI
- D-RT-7600SV, 06947024409737
- Basic UDI-DI
- B-RT-7600SV, 694702440026058
- EMDN Code
- W0202010201 Automated 3 part hematology analysers
- Device Class
- Class IVD GeneralClass B
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000011141
- 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 (2)
- EUDAMED 2758cadb-7e3a-42d0-bf19-ef4e0dd68937
- EUDAMED 06947024409737|694702440026058