PATHFAST Presepsin
by PHC Corporation Japan EUDAMED
Ref 30125
EMDN W01029099
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number4987595PF1201KX3 | Date27 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Certificates
- V76 123901 0007 Issued
Technical documentation EU IVDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 5 Jun 2026
- Expires
- 28 Feb 2028
Specification
- Model / Reference
- 30125
- Primary DI / UDI-DI
- 04987595301254
- Basic UDI-DI
- 4987595PF1201KX3
- EMDN Code
- W01029099 Immunochemistry reagents - other
- Device Class
- Class C
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- JP-MF-000008516
- Authorised representative
- PHC Europe B.V. NL-AR-000002692
Other devices from Phc Corporation
Properties & raw data
Show properties, registry sources and raw records
Other properties (6)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 04987595301254|4987595PF1201KX3