cTnI Quantitative Test Kit (Time-Resolved FIA)
by Zhejiang Orient Gene Biotech Co., Ltd China EUDAMED
Ref FDTRO-402b-DRHGModel FDTRO-402b-DR10, FDTRO-402b-DR10LH, FDTRO-402b-DR10HG, FDTRO-402b-DR, FDTRO-402b-DRLH, FDTRO-402b-DRHG
EMDN W0102160703
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69509960FDTRO-402b-DRDH | Date22 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Certificates
- 6188440TD07 Issued
Technical documentation EU IVDR
- Notified body
- Notified body 0344
- Issued
- 13 Feb 2026
- Expires
- 1 Feb 2031
- 6188440CE01 Supplemented
Quality management system EU IVDR
- Notified body
- Notified body 0344
- Issued
- 1 Sep 2026
- Expires
- 1 Apr 2030
- Reason
- Add device or group
Specification
- Model / Reference
- FDTRO-402b-DR10, FDTRO-402b-DR10LH, FDTRO-402b-DR10HG, FDTRO-402b-DR, FDTRO-402b-DRLH, FDTRO-402b-DRHG
- Primary DI / UDI-DI
- 06950996055918
- Basic UDI-DI
- 69509960FDTRO-402b-DRDH
- Direct Marketing DI
- 06950996055918
- EMDN Code
- W0102160703 Troponin i/t - rt & poc
- Device Class
- Class C
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000017965
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Zhejiang Orient Gene Biotech Co., Ltd.
See all devices from Zhejiang Orient Gene Biotech Co., Ltd. →
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 06950996055918|69509960FDTRO-402B-DRDH