Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
Mission Ultra Cholesterol Monitoring System
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-C111-5011RF
- Basic UDI-DI Code
- B-C111-5011RF
- Reference
- C111-5011
- 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 Mission Ultra Cholesterol Monitoring System is intended 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. The Mission Ultra Cholesterol Monitoring System consists of Mission Ultra Cholesterol Meter, Mission Ultra Total Cholesterol Test Strips and Mission Ultra Cholesterol Control Solution, and it is for self-testing and professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
| W0101060102 | CHOLESTEROL TEST STRIPS |
| 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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