Pure Global

Cardiac electrophysiology application software

Access comprehensive regulatory information for Cardiac electrophysiology application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Ironbark Creek Investments, manufactured by VectraCor Inc in United States of America. The device registration started on March 02, 2018.

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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Class IIb
Class IIb
Cardiac electrophysiology application software
Australia TGA ARTG Registered Device
Good Name: Ironbark Creek Investments - Cardiac electrophysiology application software
Pure Global
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Intended Purpose

Computerised analysis of cardiac electrical data from ECG leads to detect acute myocardial ischaemic injury including AMI (acute myocardial infarction) for patients presenting with chest pain or presumed ACS (acute coronary syndrome).

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 02, 2018
Effective Date
March 02, 2018
Manufacturer
Country
United States of America
Address
785 Totowa Road Suite 100, Totowa, NJ, 07512