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Cardiac radio-frequency ablation system - ARTG 385810

Access comprehensive regulatory information for Cardiac radio-frequency ablation system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 385810 and sponsored by Regional Health Care Group Pty Ltd, manufactured by Livetec Ingenieurburo GmbH in Germany. The device registration started on March 17, 2022.

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
ARTG 385810
Class IIb
Cardiac radio-frequency ablation system
ARTG ID: 385810
Good Name: Regional Health Care Group Pty Ltd - Cardiac radio-frequency ablation system
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Intended Purpose

The HAT 500ยฎ is a specialised radio- frequency ablation generator.Its purpose is the performance of intracardiac RF ablation therapies and ablation therapies in the renal artery.It is supplied with a remote control. It is designed for use with the HAT 500ยฎ Pump. This device is not supplied with the ablation catheters.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
385810
Start Date
March 17, 2022
Effective Date
March 17, 2022
Manufacturer
Country
Germany
Address
8 Marie-Curie-Strasse, Lorrach, 79539