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 I-Sens Inc in South Korea. The device registration started on April 23, 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.
Blood glucose test strips and Blood glucose monitoring system intended for in-vitro (outside the body) diagnostic use for self-testing and used for the quantitative measurement of the glucose level as an aid in monitoring diabetes management. The Blood Glucose Monitoring System cannot be used for the diagnosis of diabetes. The coding of the test strips is automatically detected. The test result is plasma equivalent and achieved by using (a) fresh capillary whole blood that may be drawn from the fingertip (b) and venous whole blood samples if drawn by healthcare professionals.