XPER Technology Procheck Advance Multi-Functional Monitoring System

Primary DI

04713106028705

Basic UDI-DI Code

B-04713106028705

Reference

TD-4206

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd Annex 2 List B

Status

On The Market

Manufacturer

TaiDoc Technology Corporation

This system is intended for use outside the body (in vitro diagnostic use) to quantitatively measure the biochemical parameter - blood glucose, β-ketone and total cholesterol in fresh capillary whole blood. It is for self-testing or for healthcare professional use. It should NOT be used for diagnosis or screening of diseases. Professionals may also use the test strips for blood glucose measurement in venous, arterial, neonatal whole blood and for β-ketone measurement in venous whole blood. Self-testing is limited to doing all biochemical parameter testing with fresh capillary whole blood.

Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).