Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
FSH One Step Menopause Test
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06939663986014
- Basic UDI-DI Code
- B-06939663986014
- Reference
- Strip,Cassette,Midstream
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Sejoy Biomedical Co., Ltd.
Additional Description
The FSH One Step Menopause Test is a rapid lateral flow chromatographic immunoassay for the qualitative detection of Follicle-Stimulating Hormone (FSH) level in urine to evaluate the onset of menopause in women.For self-testing in vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160301 | FSH - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 095295 0002 | TÜV SÜD Product Service GmbH | Expired |
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