Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
One Step HCG Pregnancy Test
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- 06946679305883
- Basic UDI-DI Code
- B-06946679305883
- Reference
- AD001
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Wuhan J.H. Bio-Tech Co., Ltd.
Additional Description
The test paper is used for all levels of medical institutions for early diagnosis of patients with early pregnancy and patients at home for self-testing. The One Step HCG Pregnancy Test (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (HCG) in 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) | HL 2409548-1 | TÜV Rheinland LGA Products GmbH | Expired |
Available In Countries
🇫🇷 France
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