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 Australian Medical Systems Pty Ltd, manufactured by SonoScape Medical Corp in China. The device registration started on March 02, 2018.

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: Australian Medical Systems Pty Ltd - Ultrasound system, imaging, general-purpose
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Intended Purpose

A general-purpose diagnostic ultrasound imaging system designed exclusively for use in a wide variety of both extracorporeal and/or intracorporeal (endosonography or endoscopic) body imaging procedures. A general-purpose system supports a wide variety of transducers and related application software packages allowing for the collection, display and analysis of ultrasound information. Usages are, e.g. general-purpose imaging, cardiac, OB/GYN, endoscopy, breast, prostate, vascular, intra-surgical, Doppler or colour Doppler, depending on the operating system specific software packages and compatible ultrasound transducers.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 02, 2018
Effective Date
March 02, 2018
Manufacturer
Country
China
Address
4/F 5/F 8/F 9/F & 10/F Yizhe Building Yuquan Road Nanshan, Shenzhen, Guangdong, 518051