Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
hCG One Step Pregnancy Test
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06939663982061
- Basic UDI-DI Code
- B-06939663982061
- Reference
- Strip,Cassette,Midstream
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Sejoy Biomedical Co., Ltd.
Additional Description
The hCG One Step Pregnancy Test is a rapid, one-step lateral flow immunoassay in strip, device and/or midstream format for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the 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) | V1 095295 0002 | TÜV SÜD Product Service GmbH | Expired |
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