Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
One Step Ovulation Test
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-6909620WHSLH8KD2
- Basic UDI-DI Code
- B-6909620WHSLH8KD2
- Reference
- WH-FT-S0x0201; WH-FT-S0x0202; WH-FT-S0x0203; WH-FT-S0x0207
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- W.H.P.M. Bioresearch & Technology Co., Ltd.
Additional Description
The One step Ovulation Test is a self-testing immunochromatographic one step assay designed for in vitro qualitative determination of human Luteinizing Hormone (hLH) in urine to predict time of ovulation.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160304 | LH - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 2101523-1 | TÃœV Rheinland LGA Products GmbH | Expired |
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