Sainsbury's Health Matters 2 Pregnancy
Ref 00188
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-05060100939513 05060100939513 | Date22 Sep 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- Sainbury's Pregnancy Midstream Twin
- Model / Reference
- 00188
- Primary DI / UDI-DI
- 05060100939513
- Basic UDI-DI
- B-05060100939513
- EMDN Code
- W0102160302 Hcg - rt & poc
- Device Class
- Class IVD devices for self-testing
- EU market of registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- XI-MF-000025280
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No