Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
Mission HDL High Density Lipoprotein Test Devices
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-C131-2031S2
- Basic UDI-DI Code
- B-C131-2031S2
- Reference
- C131-2031
- 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 HDL High Density Lipoprotein Test Devices is used with the Cholesterol Meter to measure the High Density Lipoprotein (HDL) in whole blood, plasma and serum during professional testing. For self-testing use fingertip blood.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060103 | HDL TEST STRIPS |
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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