Electrocardiogrpahic Ambulatory Recorder - Patient data recorder, long-term, electrocardiograph - ARTG 392044
Access comprehensive regulatory information for Electrocardiogrpahic Ambulatory Recorder - Patient data recorder, long-term, electrocardiograph in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 392044 and sponsored by Vicki Partridge Pty Ltd, manufactured by TZ Medical Inc in United States of America. The device registration started on July 11, 2022.
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 device is a battery operated ambulatory electrocardiograph recorder for use in Holter recording. The device is capable of storing 3 channels of patient ECG data acquired from 3 surface electrodes adhered to the body for over <30 days of continuous recording. The device is intended for use by individuals who are at risk of having cardiac disease and those that have intermittent symptoms indicative of cardiac disease and demonstrated a need to be monitored on a continuing basis.