Clinical chemistry substrate IVDs
Access comprehensive regulatory information for Clinical chemistry substrate IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Ypsomed Australia Pty Ltd, manufactured by Bionime Corporation in Taiwan. The device registration started on April 23, 2018.
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.
Blood glucose monitoring system/test strips to be used for the quantitative measurement of glucose (sugar) in fresh capillary, venous, arterial, and neonatal whole blood samples. Fresh capillary samples may be drawn from the fingertip, palm and forearm, and in the case of neonates, the heel.