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Brain/neuromuscular intraoperative electrical stimulation system pulse generator - ARTG 473645

Access comprehensive regulatory information for Brain/neuromuscular intraoperative electrical stimulation system pulse generator in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 473645 and sponsored by Compumedics Limited, manufactured by EMS Handels Gesellschaft mbH in Austria. The device registration started on December 18, 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.

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Class IIa
ARTG 473645
Class IIa
Brain/neuromuscular intraoperative electrical stimulation system pulse generator
ARTG ID: 473645
Good Name: Compumedics Limited - Brain/neuromuscular intraoperative electrical stimulation system pulse generator
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Intended Purpose

The EMS Neurostimulator is intended to be used for neurophysiological stimulation of the motor nerves , brain areas and muscles during electrophysiological applications , as an additional aid in surgical procedures and for supporting of diagnosis in neurological diseases. The EMS neurostimulator is not intended for monitoring of life-supporting functions. The device is intended to be used for continuous operation. (use for a period of up to 30 days under normal conditions of operation). The EMS Neurostimulator is indicated for use on patients with neurological diseases for brain stimulation, muscle and nerve stimulation.

Device Classification
Risk Class
Class IIa
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
473645
Start Date
December 18, 2024
Effective Date
December 18, 2024
Manufacturer
Country
Austria
Address
Jochingergasse 1, Korneuburg, A-2100