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HIFU system - Ultrasonic body-contouring system - ARTG 296514

Access comprehensive regulatory information for HIFU system - Ultrasonic body-contouring system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 296514 and sponsored by Elogio Asia Aust Pty Ltd, manufactured by Newpong Co Ltd in South Korea. The device registration started on November 20, 2017.

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 296514
Class IIb
HIFU system - Ultrasonic body-contouring system
ARTG ID: 296514
Good Name: Elogio Asia Aust Pty Ltd - HIFU system - Ultrasonic body-contouring system
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Intended Purpose

A non-invasive therapeutic device for the treatment of lipomas using the principle of coagulation and necrosis in the body. A Focused Ultrasound Therapeutic System providing a non-invasive approach to deliver Focused Ultrasound Energy to eliminate mature adipose tissue located in the subcutaneous tissues.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
296514
Start Date
November 20, 2017
Effective Date
November 20, 2017
Manufacturer
Country
South Korea
Address
1004 Medical Device Complx Center 200 Gieopdosi-ro Jijeong-myeon Wonju-si, Gangwon-do, 220-821