Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
One Step Pregnancy Test Kit (Colloidal Gold immunochromatographic Assay)
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06975228760132
- Basic UDI-DI Code
- B-06975228760132
- Reference
- ESWT-C-FHC-03
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
Additional Description
Easysweet hCG Test Cassette is an in vitro diagnostic (IVD) qualitative test for rapid detection of hCG in urine. This test is designed for self-testing use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102050205 | TOTAL HUMAN CHORIONIC GONADOTROPIN |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No.V1 069762 0007 | TÜV SÜD Product Service GmbH |
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