Australia TGA ARTG record

Electrocardiographic long-term ambulatory recorder/analyser

Australia TGA ARTG Registered Device · Propell Pty Ltd ATF Propell Trust · Andon Health Co Ltd · Class IIa · Started October 20, 2020

Good Name: Propell Pty Ltd ATF Propell Trust - Electrocardiographic long-term ambulatory recorder/analyser

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: October 20, 2020
Effective Date: October 20, 2020

Sponsor

Name: Propell Pty Ltd ATF Propell Trust

Manufacturer

Name: Andon Health Co Ltd
Country: China
Address: No 3 Jinping Street YaAn Road, Tianjin, Nankai District, 300190

Intended purpose

The ECG3 Portable ECG Monitor is intended for use in a community hospital or at home and it is a dynamic electrocardiogram measurement system. It is designed to measure and record ECG data of an adult individual in the long term by using a technique in which an electrode was pasted on the chest. The ECG3 Portable ECG Monitor is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, lightheadedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety.

About this record

Access comprehensive regulatory information for Electrocardiographic long-term ambulatory recorder/analyser in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Propell Pty Ltd ATF Propell Trust, manufactured by Andon Health Co Ltd in China. The device registration started on October 20, 2020.

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.