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General ultrasound imaging system, battery-powered

Access comprehensive regulatory information for General ultrasound imaging system, battery-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Sonictec, manufactured by Sonostar Technologies Co Limited in China. The device registration started on April 30, 2019.

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 IIa
Class IIa
General ultrasound imaging system, battery-powered
Australia TGA ARTG Registered Device
Good Name: Sonictec - General ultrasound imaging system, battery-powered
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Intended Purpose

A battery-powered, hand-held device/device assembly designed to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addition be intended to be used with a sterile cover for intraoperative imaging. It consists of a flat- or concave-lensed ultrasound transducer and includes an integrated image processing system; it may include an integrated display or be intended to wirelessly transmit images to an off-the-shelf device (e.g., smartphone, tablet) with dedicated software installed.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
April 30, 2019
Effective Date
April 30, 2019
Sponsor
Manufacturer
Country
China
Address
504 C Building 27 Yayingshi Road Science Town, Guangzhou, 510665