Australia TGA ARTG record

Electrocardiograph, Holter analyser

Australia TGA ARTG Registered Device · Ecomed Pty Ltd · Spacelabs Healthcare Ltd · Class IIa · Started August 25, 2023

Good Name: Ecomed Pty Ltd - Electrocardiograph, Holter analyser

Device classification

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

Registration information

Start Date: August 25, 2023
Effective Date: August 25, 2023

Sponsor

Name: Ecomed Pty Ltd

Manufacturer

Name: Spacelabs Healthcare Ltd
Country: United Kingdom
Address: Unit B Foxholes Centre John Tate Road, Hertford, Hertfordshire, SG13 7DT

Intended purpose

To analyze recordings of ambulatory electrocardiograms made on compatible ECG recorders. Capable of e.g. analyzing the ECG, detecting certain arrhythmias, allowing the user to view and edit analysis results, correlating symptomatic patient events and construct a report for use by Physicians / Cardiologists. May also be able to be used as a triage tool for assessment of ambulatory ECG from supported devices, supporting selection and export of ECG segments for more detailed analysis in a compatible analyzer.

About this record

Access comprehensive regulatory information for Electrocardiograph, Holter analyser in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Ecomed Pty Ltd, manufactured by Spacelabs Healthcare Ltd in United Kingdom. The device registration started on August 25, 2023.

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.