Preview™ Ovulation Test
by Guangzhou Wondfo Biotech Co., Ltd. China EUDAMED
Ref W002P0320Model Strip, Cassette, Midstream (types M, M4, M18, MII and M9)
EMDN W0102160304
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69332898CE1218F4 | Date17 Sep 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Certificates
- V76 058008 0051 Issued
Technical documentation EU IVDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 14 Sep 2026
- Expires
- 13 Sep 2031
Specification
- Device Name
- One Step Ovulation Test
- Model / Reference
- Strip, Cassette, Midstream (types M, M4, M18, MII and M9), W002P0320
- Primary DI / UDI-DI
- 06933289845564
- Basic UDI-DI
- 69332898CE1218F4
- EMDN Code
- W0102160304 Lh - rt & poc
- Device Class
- Class B
- Market of Registration
- Denmark
Manufacturer details
- EUDAMED SRN
- CN-MF-000000689
- Authorised representative
- QbD RepS BV BE-AR-000000040
Other devices from Guangzhou Wondfo Biotech Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 06933289845564|69332898CE1218F4