Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
FSH - RT & POC
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-CNM0000180726003N4
- Basic UDI-DI Code
- B-CNM0000180726003N4
- Reference
- 6003C 6003S 6003D 6003B
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Shanghai Chemtron Biotech Co., Ltd.
Additional Description
One-Step Menopause FSH Test is made for the rapid detection of human Follicle Stimulating Hormone (FSH) in urine specimens. This test device is used for evaluation with the onset of menopause and is intended for self-testing.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160301 | FSH - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 076482 0004 | TÜV SÜD Product Service GmbH | Expired |
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