Eu Ivdd
Eu Ivd Self Testing
On The Market
🇹🇼 Taiwan
BeneCheck Hb Hemoglobin Control Solution
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-BK-CSH329T
- Basic UDI-DI Code
- B-BK-CSH329T
- Reference
- BK-CSH32
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- General Life Biotechnology Co., Ltd.
Additional Description
Hb hemoglobin control solution (level 2)
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0103010606 | HAEMATOLOGY CONTROLS - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 2029595-1 | TÜV Rheinland LGA Products GmbH | Expired |
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