Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
CLIN. CHEM. RT & POC - OTHER
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06936983107792
- Basic UDI-DI Code
- B-06936983107792
- Reference
- OSC-902H
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Hangzhou Alltest Biotech.Co.,Ltd.
Additional Description
The Sperm Concentration Rapid Test is biochemical assay for in vitro qualitative estimation of sperm concentration in human semen as an auxiliary aid in clinical diagnosis of the infertility and/or pregnancy planning by self-evaluation of sperm concentration above or below the required concentration for successful pregnancy.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010699 | CLIN. CHEM. RT & POC - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No.V1 095123 0008 | TÜV SÜD Product Service GmbH | Expired |
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