Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
QUIK-CHECK Cholesterol Meter
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-C111-2027R9
- Basic UDI-DI Code
- B-C111-2027R9
- Reference
- C111-2027
- 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 Cholesterol Meter is intended to be used with QUIK-CHECK Cholesterol Test Devices for the quantitative determination of Total Cholesterol (CHOL), High-Density Lipoprotein (HDL), and Triglycerides (TRIG) in capillary and venous whole blood, serum and plasma. The value of Low-Density Lipoprotein (LDL) and the ratio of CHOL/HDL are calculated by the QUIK-CHECK Cholesterol Meter. The QUIK-CHECK Cholesterol Meter 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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