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Interpretive multichannel electrocardiograph

Access comprehensive regulatory information for Interpretive multichannel electrocardiograph in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Cardio-Jenic Pty Ltd, manufactured by Heart Test Laboratories Inc dba Heart Sciences in United States of America. The device registration started on August 25, 2017.

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
Interpretive multichannel electrocardiograph
Australia TGA ARTG Registered Device
Good Name: Cardio-Jenic Pty Ltd - Interpretive multichannel electrocardiograph
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Intended Purpose

The MyoVista Wavelet ECG (wavECG) Cardiac Testing Device (MyoVista Device) is a 12-lead resting electrocardiograph with conventional interpretive analysis of the ECG waveform and MyoVista wavelet signal processed information. The MyoVista wavelet signal processed information is intended to be used as an aid in diagnosis by means of analysis of the ECG waveform in the frequency domain.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 25, 2017
Effective Date
August 25, 2017
Manufacturer
Country
United States of America
Address
550 Reserve Street Suite 360, Southlake, Texas, 76092