Australia TGA ARTG record

HearCare MED-EL - Hearing aid fitting/programming application software

Australia TGA ARTG Registered Device · MED-EL Implant Systems Australasia Pty Ltd · Med-El Elektromedizinische Gerate GmbH · Class III · Started April 09, 2024

Good Name: MED-EL Implant Systems Australasia Pty Ltd - HearCare MED-EL - Hearing aid fitting/programming application software

Device classification

Risk Class: Class III
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: April 09, 2024
Effective Date: April 09, 2024

Sponsor

Name: MED-EL Implant Systems Australasia Pty Ltd

Manufacturer

Name: Med-El Elektromedizinische Gerate GmbH
Country: Austria
Address: Furstenweg 77a, Innsbruck, 6020

Intended purpose

A mobile application that can perform technical checks on compatible MED-EL cochlear implants and audio processors, as well as install audio processor configurations, and create and install configuration backups.

About this record

Access comprehensive regulatory information for HearCare MED-EL - Hearing aid fitting/programming application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by MED-EL Implant Systems Australasia Pty Ltd, manufactured by Med-El Elektromedizinische Gerate GmbH in Austria. The device registration started on April 09, 2024.

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.