Automatic Coagulation Analyzer
by SysCan MedTech (Suzhou) Co., Ltd China EUDAMED
Ref Ci-120nModel Ci-120/Ci-120i/Ci-120x/Ci-120n
EMDN W0202020102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697370391Model004GK | Date8 Mar 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- Ci-120/Ci-120i/Ci-120x/Ci-120n, Ci-120n
- Primary DI / UDI-DI
- 06973703911062
- Basic UDI-DI
- 697370391Model004GK
- Direct Marketing DI
- 06973703911062
- EMDN Code
- W0202020102 Automated coagulometers
- Device Class
- Class A
- Market of Registration
- Romania
Manufacturer details
- EUDAMED SRN
- CN-MF-000039109
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from SysCan MedTech (Suzhou) Co., Ltd
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 9b42b758-254f-46f5-80ec-12929f7d0bbc