Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
One Step HCG Urine Pregnancy Rapid Test Kit (Colloidal Gold)
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06935091671980
- Basic UDI-DI Code
- B-06935091671980
- Reference
- /
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Qingdao Hightop Biotech Co., Ltd.
Additional Description
The human chorionic gonadotrophin rapid test kit is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. For self-testing.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160302 | HCG - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No. V1 093780 0004 Rev. 01 | TÜV SÜD Product Service GmbH | Expired |
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