LH Ovulation Rapid Test Strip
by Medotex Biotech (HangZhou) Co., Ltd.
Ref LH-101a
Active
CE IVDR 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 | Number69798909110055D4 | Date3 Sep 2026 | StatusActive |
| European Union | CE/IVDR | Number69798909110055D4 | Date3 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- Withdrawn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, CE/IVDR Active
Specification
- Device Name
- LH Ovulation Rapid Test Strip
- Model / Reference
- LH-101a
- Primary DI / UDI-DI
- 06979890910383, D-LH-101aKC
- Basic UDI-DI
- 69798909110055D4, B-LH-101aKC
- EMDN Code
- W0102160304 Lh - rt & poc
- Device Class
- Class BClass IVD General
- Market of Registration
- GreeceGermany
Manufacturer details
- EUDAMED SRN
- CN-MF-000051631
- Authorised representative
- Llins Service & Consulting GmbH DE-AR-000009077
Other devices from Medotex Biotech (HangZhou) Co., Ltd.
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No