PSA Quantitative Test Kit (Time-Resolved FIA)
by Zhejiang Orient Gene Biotech Co., Ltd China EUDAMED
Ref FEPSA-402a-DRLHModel 10 tests/kit EMDN W0102030113
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69509960FEPSA-402a-DRZB | Date25 Nov 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- 6188440TD02 Issued
Technical documentation EU IVDR
- Notified body
- Notified body 0344
- Issued
- 19 Jun 2025
- Expires
- 1 Jun 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
- PSA Quantitative Test Kit (Time-Resolved FIA)
- Model / Reference
- 10 tests/kit, FEPSA-402a-DRLH
- Primary DI / UDI-DI
- 06950996064521
- Basic UDI-DI
- 69509960FEPSA-402a-DRZB
- EMDN Code
- W0102030113 Total prostatic specific antigen
- 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.
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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 06950996064521|69509960FEPSA-402A-DRZB