hey mela Schwangerschaftstest
by VELLAP Diagnostics GmbH EUDAMED
Active
Ref 2.13.1.715
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number426074347.2.13.1.704.5G | Date23 Jan 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- IX 2512862-2 Issued
Technical documentation EU IVDR
- Notified body
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 24 Jul 2025
- Expires
- 23 Jul 2030
Specification
- Model / Reference
- 2.13.1.715
- Primary DI / UDI-DI
- 04260743470737
- Basic UDI-DI
- 426074347.2.13.1.704.5G
- Direct Marketing DI
- 04260743470737
- EMDN Code
- W0102050205 Total human chorionic gonadotropin
- Device Class
- Class B
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000035636
Other devices from VELLAP Diagnostics GmbH
Properties
Show properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Reagent: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No