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LH Ovulation Rapid Tests
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref WSLH1001,WSLH1002,WSLH1003Model Strip,Cassette,Midstream
Identity
- Trade Name
- LH Ovulation Rapid Tests EUDAMED
- Device Name
- LH Ovulation Rapid Tests EUDAMED
- Model / Reference
- Strip,Cassette,Midstream EUDAMEDWSLH1001,WSLH1002,WSLH1003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-WSLH100A9 EUDAMED
- Basic UDI-DI
- B-WSLH100A9 EUDAMED
- EMDN Code
- W0102160304 LH - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
LH Ovulation Rapid Tests by Hangzhou Clongene Biotech Co., Ltd. — Class IVD devices for self-testing — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-WSLH100A9 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Hangzhou Clongene Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000030069
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED bac752bd-8ed3-453e-9e82-a50daa7f865f 61 fields · synced Jun 17, 2026
- EUDAMED bac752bd-8ed3-453e-9e82-a50daa7f865f-1 61 fields · synced Jun 10, 2026