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Analyser software, application program - ARTG 198466

Access comprehensive regulatory information for Analyser software, application program in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 198466 and sponsored by Intervene Medical Pty Ltd, manufactured by Medis Medical Imaging System bv in Netherlands. The device registration started on June 14, 2012.

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
ARTG 198466
Class IIa
Analyser software, application program
ARTG ID: 198466
Good Name: Intervene Medical Pty Ltd - Analyser software, application program
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Intended Purpose

The intended purposes of the Medis software is to assist in Cardiac analysis of a patient post coronary investigations performed in a Cardiac Cath lab by a cardiologist. Analysis that can be performed is of the ventricles and or coronary arteries.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
198466
Start Date
June 14, 2012
Effective Date
June 14, 2012
Manufacturer
Country
Netherlands
Address
Schuttersveld 9, Leiden, 2316 XG