Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
HCG - RT & POC
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06936983119139
- Basic UDI-DI Code
- B-06936983119139
- Reference
- FHC-U101H
- 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 hCG Pregnancy Enhanced Sensitivity Rapid Test Dipstick (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in human urine to aid in the early detection of pregnancy.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160302 | HCG - RT & POC |
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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