Australia TGA ARTG record

Interpretive multichannel electrocardiograph

Australia TGA ARTG Registered Device · Cardio-Jenic Pty Ltd · Heart Test Laboratories Inc dba Heart Sciences · Class IIa · Started August 25, 2017

Good Name: Cardio-Jenic Pty Ltd - Interpretive multichannel electrocardiograph

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

Sponsor

Name: Cardio-Jenic Pty Ltd

Manufacturer

Name: Heart Test Laboratories Inc dba Heart Sciences
Country: United States of America
Address: 550 Reserve Street Suite 360, Southlake, Texas, 76092

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.

About this record

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.