Semi-auto Coagulation Analyzer
by Rayto Life and Analytical Sciences Co., Ltd. EUDAMED
Active
Ref RT-2202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number694702440057462 | Date23 Mar 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- RT-2202
- Primary DI / UDI-DI
- 06947024409508
- Basic UDI-DI
- 694702440057462
- Direct Marketing DI
- 06947024409508
- EMDN Code
- W0202020101 Semi-automated coagulometers
- Device Class
- Class A
- 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
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