Multichannel electrocardiograph, interpretive, home-use
Access comprehensive regulatory information for Multichannel electrocardiograph, interpretive, home-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Quintessa Holdings Pty Ltd, manufactured by Coala-Life AB in Sweden. The device registration started on May 18, 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 product is a small hand-held device that is pressed against the chest for simultaneous recordings of ECG and heart sounds through electrodes and a stethoscope membrane. It is intended for use by healthcare professionals or individuals with known or suspected heart conditions and health conscious individuals. It is not intended for use for vital monitoring as in intensive care.