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Ultrasound system, imaging, general-purpose

Australia TGA ARTG Registered Device · Ultramedix Australasia Pty Ltd · Shantou Institute of Ultrasonic Instruments Co Ltd · Class IIa · Started February 16, 2022

Good Name: Ultramedix Australasia Pty Ltd - Ultrasound system, imaging, general-purpose

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
Start Date
February 16, 2022
Effective Date
February 16, 2022
Sponsor
Manufacturer
Country
China
Address
77 Jinsha Road Shantou SEZ, Shantou, 515041
Intended purpose

System designed to be used with attached ultrasound transducers for the imaging, measurement, calculation and recording of anatomic structures and blood flow and guidance of needle placement. These general purpose systems support a wide variety of transducers and related software packages for the collection, display and analysis of ultrasound information.

About this record

Access comprehensive regulatory information for Ultrasound system, imaging, general-purpose in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Ultramedix Australasia Pty Ltd, manufactured by Shantou Institute of Ultrasonic Instruments Co Ltd in China. The device registration started on February 16, 2022.

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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