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UTIMS A3 PLUS - Ultrasonic skin contouring system

Access comprehensive regulatory information for UTIMS A3 PLUS - Ultrasonic skin contouring system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by CSHE Australia Pty Ltd, manufactured by Korust Co Ltd in South Korea. The device registration started on April 19, 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 IIb
Class IIb
UTIMS A3 PLUS - Ultrasonic skin contouring system
Australia TGA ARTG Registered Device
Good Name: CSHE Australia Pty Ltd - UTIMS A3 PLUS - Ultrasonic skin contouring system
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Intended Purpose

Assemble of devices intended to use High Intensity focused ultrasound applied to tissues of Face and Body areas. The ultrasound energy is concentrated at the focal point and coagulation points are created in the skin for skin rejuvenation. The size of thermal coagulation point is decided by the intensity of therapeutic ultrasound energy and the energy distribution of the focal point. The device is intended to be used over the facial and Body areas.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
April 19, 2021
Effective Date
April 19, 2021
Manufacturer
Country
South Korea
Address
B-#716 717 718 Keumkang Penterium IT Tower 282 Hagui-ro Dong an-gu, Anyang-si, Gyeong gi-do, 14056