Saliva Pregnancy Test Kit
by BioTeke Corporation（Wuxi）Co., Ltd China EUDAMED
Ref ICA2235Model 1 Test/Kit,2 Tests/kit,5 Tests/kit,20 Tests/ EMDN W0102160302
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697454156019LE | Date28 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- EU-TDA-FI-43117-800031-2025 Issued
Technical documentation EU IVDR
- Notified body
- Notified body 3018
- Issued
- 9 Jul 2026
- Expires
- 30 May 2030
Specification
- Model / Reference
- 1 Test/Kit, 2 Tests/kit, 5 Tests/kit, 20 Tests/, ICA2235
- Primary DI / UDI-DI
- 06974541565721, 06974541565745
- Basic UDI-DI
- 697454156019LE
- EMDN Code
- W0102160302 Hcg - rt & poc
- Device Class
- Class B
- Market of Registration
- AustriaGermany
Manufacturer details
- EUDAMED SRN
- CN-MF-000007517
- Authorised representative
- Medunion S.L. ES-AR-000019366
Other devices from Bioteke Corporation (Wuxi) Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (2)
- EUDAMED 285c535a-2e2b-4d3a-9e5c-d4bbc9378ef7
- EUDAMED 06974541565745|697454156019LE