LH Ovulation (LH) Rapid Test Cassette
by Hangzhou Alltest Biotech.Co., Ltd.
Ref FLH-102H
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-06936983105880 06936983105880 | Date23 Feb 2023 | 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- Withdrawn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
- Ovulation (LH) Rapid Test Cassette
- Model / Reference
- FLH-102H
- Primary DI / UDI-DI
- 06936983105880
- Basic UDI-DI
- B-06936983105880
- EMDN Code
- W0102160304 Lh - rt & poc
- Device Class
- Class IVD devices for self-testing
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000010710
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Hangzhou Alltest Biotech.Co., Ltd.
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No