SuperFlex High Sensitivity Cardiac Troponin I Kit
by Suzhou Sym-Bio Lifescience Co., Ltd. China EUDAMED
Ref SDX-57015Model 50 tests EMDN W01021306
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69510458SF_cTnIFG | Date30 Jun 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- SuperFlex High Sensitivity Cardiac Troponin I Kit
- Model / Reference
- 50 tests, SDX-57015
- Primary DI / UDI-DI
- 06951045810076
- Basic UDI-DI
- 69510458SF_cTnIFG
- EMDN Code
- W01021306 Troponin i/t
- Device Class
- Class C
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000012847
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Suzhou Sym-Bio Lifescience Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 96a19a75-2122-439e-8464-830b5515035c