Instrument/analyser IVDs - ARTG 356594
Access comprehensive regulatory information for Instrument/analyser IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 356594 and sponsored by Propell Pty Ltd ATF Propell Trust, manufactured by Andon Health Co Ltd in China. The device registration started on March 11, 2021.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
The iHealth Wireless Smart Glucose Meter (BG5S)- - Self Testing is intended to be used with iHealth Test Strips (EGS-2003) for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Wireless Smart Glucose Meter (BG5S)- - Self Testing is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should not be used for the diagnosis of or screening of diabetes or for neonatal use.