Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
HCG - RT & POC
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-CNM0000180726001MY
- Basic UDI-DI Code
- B-CNM0000180726001MY
- Reference
- 6001C 6001S 6001D 6001B
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Shanghai Chemtron Biotech Co., Ltd.
Additional Description
One-Step HCG Pregnancy Test is made for the rapid detection of human chorionic gonadotropin (HCG) in urine specimens. This test kit is used to obtain a visual, qualitative result and is intended 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) | No.V1 076482 0004 | TÜV SÜD Product Service GmbH | Expired |
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