LH Ovulation Test (Colloidal Gold)
by Anhui Deepblue Medical Technology Co., Ltd 10 variants
Ref LH3UST- 50, LH3UST-50Model Cassette Strip Midstream
Active
CE IVDR CE IVDD
Valid until
17 Aug 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberB-06952062779384 06952062779384 | Date17 Jun 2026 | StatusActive |
| European Union | CE/IVDD | NumberB-06952062779384 06952062779384 | Date17 Jun 2026 | StatusActive |
Certificates
- V76 003706 0008 Active
Technical documentation EU IVDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 18 Aug 2025
- Expires
- 17 Aug 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR, CE/IVDD Active
Specification
- Model / Reference
- Cassette Strip Midstream, LH3UST- 50, LH3UST-50
- Primary DI / UDI-DI
- 06952062779384
- Basic UDI-DI
- B-06952062779384, 69520627J002KY
- Unit of Use DI
- 06952062712701
- EMDN Code
- W0102050105 Luteinising hormone
- Device Class
- Class IVD GeneralClass B
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000018785
- Authorised representative
- Luxus Lebenswelt GmbH DE-AR-000005110
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Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No