LH Ovulation Rapid Test for self-testing
by Innovita (Tangshan) Biological Technology Co., Ltd. 6 variants
Ref YF105C013Model Strip: YF104S010,YF104S011; Cassette: YF105C012,YF105C013; Midstream: YF106M014.YF106M015
Active
CE IVDR
Valid until
11 Mar 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697064009YF104F3 06970640090287 | Date18 Sep 2025 | StatusActive |
Certificates
- IX 2006076-2 Active
Technical documentation EU IVDR
- Certifier
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 12 Mar 2025
- Expires
- 11 Mar 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- LH Ovulation Rapid Test for self-testing
- Model / Reference
- Strip: YF104S010, YF104S011, Cassette: YF105C012, YF105C013, Midstream: YF106M014.YF106M015
- Primary DI / UDI-DI
- 06970640090287
- Basic UDI-DI
- 697064009YF104F3
- Direct Marketing DI
- 06970640090287
- 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
Other devices from Innovita (Tangshan) Biological Technology Co., Ltd.
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Properties
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