Pure Global

Ultrasound system, imaging, general-purpose

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 Import Health Pty Ltd, manufactured by Shantou Institute of Ultrasonic Instruments Co Ltd in China. The device registration started on September 01, 2015.

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
Class IIa
Ultrasound system, imaging, general-purpose
Australia TGA ARTG Registered Device
Good Name: Import Health Pty Ltd - Ultrasound system, imaging, general-purpose
Pure Global
DJ Fang

DJ Fang

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Intended Purpose

The system is a general purpose diagnostic ultrasound imaging system designed exclusively for a range of extracorporeal body imaging procedures. Usages include, general purpose imaging, cardiac, OB/GYN, breast, prostate, vascular, Doppler or Color Doppler, depending on the operating system and specific software packages and compatible ultrasound transducers.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
September 01, 2015
Effective Date
September 01, 2015
Manufacturer
Country
China
Address
77 Jinsha Road Shantou SEZ, Shantou, 515041