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Transcranial magnetic stimulation system, mobile - ARTG 481085

Access comprehensive regulatory information for Transcranial magnetic stimulation system, mobile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 481085 and sponsored by BTL Medical Technologies Pty Ltd, manufactured by BTL Industries Limited in United Kingdom. The device registration started on February 27, 2025.

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 481085
Class IIa
Transcranial magnetic stimulation system, mobile
ARTG ID: 481085
Good Name: BTL Medical Technologies Pty Ltd - Transcranial magnetic stimulation system, mobile
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Intended Purpose

The device is intended for repetitive transcranial magnetic stimulation (rTMS). The device is intended for the treatment of Major Depressive Disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication, at or above the minimal effective dose and duration in the current episode, reduction the symptoms of comorbid anxiety in patients suffering from MDD, as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD) and treatment of Binge Eating Disorder (BED).

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
481085
Start Date
February 27, 2025
Effective Date
February 27, 2025
Manufacturer
Country
United Kingdom
Address
161 Cleveland Way, Stevenage, Hertfordshire, SG1 6BU