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Electrocardiograph, Holter analyser

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.

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TGA ARTG Official Data
Class IIa
Class IIa
Electrocardiograph, Holter analyser
Australia TGA ARTG Registered Device
Good Name: Ecomed Pty Ltd - Electrocardiograph, Holter analyser
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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.

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
Manufacturer
Country
United Kingdom
Address
Unit B Foxholes Centre John Tate Road, Hertford, Hertfordshire, SG13 7DT