PATHFAST D-Dimer
Ref 30151
PATHFAST D-Dimer (30151) is an in vitro diagnostic device (EU IVDR Class C; EMDN category D-dimer) made by Phc Corporation, registered in EUDAMED on 27 May 2026 (Basic UDI-DI 4987595PF1051KXE) with CE/IVDR certificate V76 123901 0007 valid until 28 Feb 2028, active as of 7 Nov 2026.
Active
CE IVDR
Valid until
28 Feb 2028
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberV76 123901 0007 | Date5 Jun 2026 | StatusActive |
Official records
- EUDAMED public site 4987595PF1051KXE
Certificates
- V76 123901 0007 Active
Technical documentation EU IVDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 5 Jun 2026
- Expires
- 28 Feb 2028
Timeline
- Registered EUDAMED 4987595PF1051KXE
- Certificate issued EUDAMED V76 123901 0007
- Certificate expires EUDAMED V76 123901 0007
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
- Czechia
- France
- Germany
- Greece
- Hungary
- Italy
- Lithuania
- Netherlands
- Poland
- Romania
- Slovenia
- Spain
Specification
- Model / reference
- 30151
- Primary DI / UDI-DI
- 04987595301513
- Basic UDI-DI
- 4987595PF1051KXE
- EMDN code
- W0103020503 D-dimer
- Device class
- Class C
- EU registration type
- Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- JP-MF-000008516
- Authorised representative
- PHC Europe B.V. NL-AR-000002692
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