ARTG 419990Electrocardiograph, Holter analyser
ARTG ID: 419990 · Ecomed Pty Ltd · Spacelabs Healthcare Ltd · Class IIa · Started August 25, 2023
Good Name: Ecomed Pty Ltd - Electrocardiograph, Holter analyser
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 419990
- Start Date
- August 25, 2023
- Effective Date
- August 25, 2023
- Name
- Ecomed Pty Ltd
- Country
- United Kingdom
- Address
- Unit B Foxholes Centre John Tate Road, Hertford, Hertfordshire, SG13 7DT
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.
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 registered under ARTG number 419990 and 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.