Digital LH Ovulation Test
Ref AD20-31Model Midstream
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06942468190067 06942468190067 | Date15 Sep 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Model / Reference
- Midstream, AD20-31
- Primary DI / UDI-DI
- 06942468190067
- Basic UDI-DI
- B-06942468190067
- EMDN Code
- W0102160399 Fertility/pregnancy rt & poc - other
- Device Class
- Class IVD devices for self-testing
- Market of Registration
- Denmark
Manufacturer details
- EUDAMED SRN
- CN-MF-000023522
- Authorised representative
- Wellkang Ltd XI-AR-000001836
Other devices from Core Technology Co., Ltd.
Properties
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