SaliStick
Ref SLS000001Model SaliSick
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-729001939004BY D-729001939004BY | Date15 Jul 2026 | 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- Withdrawn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
- SaliSick Saliva Pregnancy Test
- Model / Reference
- SaliSick, SLS000001
- Primary DI / UDI-DI
- D-729001939004BY
- Basic UDI-DI
- B-729001939004BY
- EMDN Code
- W0102160302 Hcg - rt & poc
- Device Class
- Class IVD devices for self-testing
- EU market of registration
- Sweden
Manufacturer details
- EUDAMED SRN
- IL-MF-000042428
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Properties
Other properties (6)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Reagent: No
- Companion Diagnostics: No
- Surgical Instrument: No