Patient data recorder, long-term, electrocardiograph - ARTG 204184
Access comprehensive regulatory information for Patient data recorder, long-term, electrocardiograph in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 204184 and sponsored by Compliance Management Solutions, manufactured by Global Instrumentation LLC in United States of America. The device registration started on December 18, 2012.
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.
Intended to be used as a Holter ambulatory electrocardiograph system for the purpose of screening for ECG rhythm disturbances over periods of up to 48-hours for a minimum 24-hour period. The Holter System is intended for use under the supervision of a physician or those knowledgeable in all aspects of ECG morphology, rhythm, and arrhythmia