Device Dossier

Clinical chemistry substrate IVDs

Device Dossier for Clinical chemistry substrate IVDs (CT833 - Clinical chemistry substrate IVDs, Class 3, sponsor Wiselink Group). ARTG record, intended…

Intended purpose

The Yuwell blood glucose meter is intended for use in quantitative measurement of glucose in human whole blood taken from the fingertip (capillary). It is intended to be used by lay person or clinical site by medical staff. The meter is used together with a blood glucose test strip to produce a result. A blood glucose control solution is included in this system.

TGA Public Summary