VELLAP D-Dimer
by VELLAP Diagnostics GmbH Germany EUDAMED
Ref 2.13.6.18
EMDN W0103020503
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberIX 2512862-1 | Date24 Jul 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Certificates
- IX 2512862-1 Issued
Technical documentation EU IVDR
- Notified body
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 24 Jul 2025
- Expires
- 23 Jul 2030
Specification
- Model / Reference
- 2.13.6.18
- Primary DI / UDI-DI
- 04260743470607
- Basic UDI-DI
- 426074347.2.13.1.500.4N
- Direct Marketing DI
- 04260743470607
- EMDN Code
- W0103020503 D-dimer
- Device Class
- Class C
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000035636
Other devices from VELLAP Diagnostics GmbH
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED ae3612e9-1389-47d1-b42e-34f5b99b1eae