Patient monitor, electrocardiograph - ARTG 315617
Access comprehensive regulatory information for Patient monitor, electrocardiograph in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 315617 and sponsored by Cardioscan Services Pty Ltd, manufactured by Edan Instruments Inc in China. The device registration started on March 20, 2019.
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 to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the interpreted ECG with measurements and interpretive statements is offered to clinicians a on an advisory basis only.