Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
QUIK-CHECK Ultra Cholesterol Meter
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-C111-5037RZ
- Basic UDI-DI Code
- B-C111-5037RZ
- Reference
- C111-5037
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Acon Biotech (Hangzhou) Co., Ltd.
Additional Description
The QUIK-CHECK Ultra Cholesterol Meter is intended to use with QUIK-CHECKTM Ultra Total Cholesterol Test Strips for the quantitative determination of Total Cholesterol in fresh fingertip capillary whole blood as an aid in diagnosis of atherosclerotic coronary artery disease and metabolic disorders involving lipids and lipoproteins. It is for self-testing and professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201069099 | VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 042074 0026 | TÜV SÜD Product Service GmbH | Expired |
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