Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
LH Ovulation Rapid Tests
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-WSLH100A9
- Basic UDI-DI Code
- B-WSLH100A9
- Reference
- WSLH1001,WSLH1002,WSLH1003
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Hangzhou Clongene Biotech Co., Ltd.
Additional Description
The LH Ovulation Rapid Test is an immuno-chromatographic assay designed for qualitative detection and the rapid determination of luteinizing hormone (LH) in urine, aid for determine of the most fertile days during the cycle. The test is intended for in vitro diagnostic self-testing.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160304 | LH - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 2041176-1 | TÜV Rheinland LGA Products GmbH | Expired |
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