Clearblue Test di gravidanza Rilevazione Precoce
by SPD Swiss Precision Diagnostics GmbH 4 variants
Ref 08700216528559Model CB14
Active
CE IVDR
Valid until
27 Oct 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberV76 099371 0030 | Date29 Oct 2025 | StatusActive |
Certificates
- V76 099371 0030 Active
Technical documentation EU IVDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 29 Oct 2025
- Expires
- 27 Oct 2030
- Reason
- Change approved
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Clearblue Ultra Early Pregnancy Test, Clearblue Pregnancy Test Ultra Early
- Model / Reference
- CB14, 08700216528559
- Primary DI / UDI-DI
- 08700216528559
- Basic UDI-DI
- 4084500CB14QT
- Unit of Use DI
- 00633472000416
- EMDN Code
- W0102160302 Hcg - rt & poc
- Device Class
- Class B
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CH-MF-000025175
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Spd Swiss Precision Diagnostics GmbH
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No