TSH Quantitative Test Kit (Time-Resolved FIA)
by Zhejiang Orient Gene Biotech Co., Ltd China EUDAMED
Ref FKTSH-402a-DRModel FKTSH-402a-DR10, FKTSH-402a-DR, FKTSH-402a-DR10HG, FKTSH-402a-DRHG, FKTSH-402a-DR10LH, FKTSH-402a-DRLH
EMDN W0102160903
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69509960FKTSH-402a-DRH9 | Date13 Jul 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Certificates
- 6188440TD11 Issued
Technical documentation EU IVDR
- Notified body
- Notified body 0344
- Issued
- 1 Jul 2026
- Expires
- 1 Jul 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
- FKTSH-402a-DR10, FKTSH-402a-DR, FKTSH-402a-DR10HG, FKTSH-402a-DRHG, FKTSH-402a-DR10LH, FKTSH-402a-DRLH
- Primary DI / UDI-DI
- 06950996003858
- Basic UDI-DI
- 69509960FKTSH-402a-DRH9
- Direct Marketing DI
- 06950996003858
- EMDN Code
- W0102160903 Thyroid-stimulating hormone - rt & poc
- Device Class
- Class B
- 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 06950996003858|69509960FKTSH-402A-DRH9