Eveline Ovulation Test
by iXensor Co., Ltd. 2 variants
Ref WHM-A01
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-04719872951971 04719872951971 | Date1 Mar 2024 | 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- Withdrawn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
- Device Name
- LH Ovulation Test
- Model / Reference
- WHM-A01
- Primary DI / UDI-DI
- 04719872951971
- Basic UDI-DI
- B-04719872951971
- EMDN Code
- W0102160304 Lh - rt & poc
- Device Class
- Class IVD devices for self-testing
- EU market of registration
- Denmark
Manufacturer details
- EUDAMED SRN
- TW-MF-000026279
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Ixensor Company, Ltd.
Properties
Other properties (9)
- 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