HCG Pregnancy Rapid Tests for self-testing
by Innovita (Tangshan) Biological Technology Co., Ltd. China EUDAMED
Ref YF102C005Model Strip:YF101S001,YF101S002,YF101S003; Cassette: YF102C004, YF102C005, YF102C006; Midstream:YF103M007.YF103M008.YF103M009 EMDN W0102160302
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697064009YF101EV | Date18 Sep 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- IX 2006076-1 Issued
Technical documentation EU IVDR
- Notified body
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 12 Mar 2025
- Expires
- 11 Mar 2030
Specification
- Device Name
- HCG Pregnancy Rapid Tests for self-testing
- Model / Reference
- Strip:YF101S001, YF101S002, YF101S003, Cassette: YF102C004, YF102C005, YF102C006, Midstream:YF103M007.YF103M008.YF103M009
- Primary DI / UDI-DI
- 06970640090256
- Basic UDI-DI
- 697064009YF101EV
- Direct Marketing DI
- 06970640090256
- EMDN Code
- W0102160302 Hcg - rt & poc
- Device Class
- Class B
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000018424
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED d1fb520a-3c78-4f90-9a0d-667705c4a18d