Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
QUIK-CHECK Cholesterol Test Device 3-in-1 Lipid Panel
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-C131-2047SH
- Basic UDI-DI Code
- B-C131-2047SH
- Reference
- C131-2047
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Acon Biotech (Hangzhou) Co., Ltd.
Additional Description
The QUIK-CHECK Cholesterol Test Devices 3-in-1 Lipid Panel is intended to be used with Cholesterol Meter for measure the lipid concentration including Total Cholesterol (CHOL), High Density Lipoprotein (HDL) and Triglycerides (TRIG) in whole blood, plasma and serum during professional testing. For self-testing use fingertip blood. It is also used to calculate LDL, CHOL/HDL and CHD risk.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060199 | BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - 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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