LH Ovulation Rapid Test for self-testing
by Innovita (Tangshan) Biological Technology Co., Ltd. China EUDAMED
Ref YF106M014Model Strip: YF104S010,YF104S011; Cassette: YF105C012,YF105C013; Midstream: YF106M014.YF106M015 EMDN W0102160304
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697064009YF104F3 | Date18 Sep 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- IX 2006076-2 Issued
Technical documentation EU IVDR
- Notified body
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 12 Mar 2025
- Expires
- 11 Mar 2030
Specification
- Device Name
- LH Ovulation Rapid Test for self-testing
- Model / Reference
- Strip: YF104S010, YF104S011, Cassette: YF105C012, YF105C013, Midstream: YF106M014.YF106M015, YF106M014
- Primary DI / UDI-DI
- 06970640090294
- Basic UDI-DI
- 697064009YF104F3
- Direct Marketing DI
- 06970640090294
- EMDN Code
- W0102160304 Lh - 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 41c72fe0-288d-4d16-b9b2-8fab1d6b6cc5