Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
Suretest Precoce
Devices (same UDI-DI)
1
Certificates
2
Countries
0
Notified Bodies
2
Basic Information
- Primary DI
- D-361481999602668
- Basic UDI-DI Code
- B-361481999602668
- Reference
- TNG25A-12E
- 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
The Pregnancy Urine Tests for Self-testing is made for the rapid self-testing of human chorionic gonadotropin (HCG) in urine specimens. This test kit is used to obtain a visual, qualitative result to aid in the detection of pregnancy.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102050206 | B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT) |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | SX 2012972-1 | TÜV Rheinland LGA Products GmbH | |
| IVDD Annex IV (excluding sections 4, 6) | HL 2012972-1 | TÜV Rheinland LGA Products GmbH | Expired |
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