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Hyperthermia system, ultrasound - ARTG 374839

Access comprehensive regulatory information for Hyperthermia system, ultrasound in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 374839 and sponsored by Soma Lasers Australia, manufactured by GTG Wellness Co Ltd in South Korea. The device registration started on September 17, 2021.

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 374839
Class IIa
Hyperthermia system, ultrasound
ARTG ID: 374839
Good Name: Soma Lasers Australia - Hyperthermia system, ultrasound
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Intended Purpose

Non invasive dermatological therapeutic device intended to be used for patients who have ptosis, psoriasis and for treatment of the wrinkle, tightening and lifting

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
374839
Start Date
September 17, 2021
Effective Date
September 17, 2021
Manufacturer
Country
South Korea
Address
A-1701-1704 902-904 Bundang Suji U-Tower 767 Sinsu-ro, Suji-gu Yonginsi, Gyeonggi-do, 16827