Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
Pregnancy Test
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06934142910092
- Basic UDI-DI Code
- B-06934142910092
- Reference
- 10161
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Tianjin New Bay Bioresearch Co., Ltd.
Additional Description
It is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the 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) | HL2012972-1 | TÜV Rheinland LGA Products GmbH | Expired |
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