D-Dimer Quantitative Test Kit (Time-Resolved FIA)
by Zhejiang Orient Gene Biotech Co., Ltd EUDAMED
Active
Ref FDDDI-402a-DR10HGModel FDDDI-402a-DR10/FDDDI-402a-DR/FDDDI-402a-DR10LH/FDDDI-402a-DRLH/FDDDI-402a-DR10HG/FDDDI-402a-DRHG
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69509960FDDDI-402a-DRCP | Date28 Nov 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- 6188440TD03 Issued
Technical documentation EU IVDR
- Notified body
- Notified body 0344
- Issued
- 23 Sep 2025
- Expires
- 1 Sep 2030
- 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
- Device Name
- D-Dimer Quantitative Test Kit (Time-Resolved FIA)
- Model / Reference
- FDDDI-402a-DR10/FDDDI-402a-DR/FDDDI-402a-DR10LH/FDDDI-402a-DRLH/FDDDI-402a-DR10HG/FDDDI-402a-DRHG, FDDDI-402a-DR10HG
- Primary DI / UDI-DI
- 06950996075381
- Basic UDI-DI
- 69509960FDDDI-402a-DRCP
- Direct Marketing DI
- 06950996075381
- EMDN Code
- W0103020503 D-dimer
- 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
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Properties
Show properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No