Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
TEST DE GROSSESSE DÉ TECTION PRÉCOCE
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06934142910047
- Basic UDI-DI Code
- B-06934142910047
- Reference
- 10156
- 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 early detection of pregnancy. With the test's high sensitivity, pregnancy can be determined as early as five days before your expected period.
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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