Australia TGA ARTG recordPortable Ultrasound Scanner - Ultrasound system, imaging, general-purpose
Australia TGA ARTG Registered Device · Australian Medical Systems Pty Ltd · Sonostar Technologies Co Limited · Class IIa · Started April 07, 2021
Good Name: Australian Medical Systems Pty Ltd - Portable Ultrasound Scanner - Ultrasound system, imaging, general-purpose
- Risk Class
- Class IIa
- Product Type
- Medical device system
- ARTG Category
- General
- Start Date
- April 07, 2021
- Effective Date
- April 07, 2021
- Country
- China
- Address
- 504 C Building 27 Yayingshi Road Science Town, Guangzhou, 510665
A battery-powered, hand-held device, designed to scan the external body surface for collection, display and analysis of ultrasound information during a variety of diagnostic ultrasound imaging procedures including Obstetrics (OB), Gynecology (GY) and General imaging. It consists of an ultrasound transducer and includes an integrated image processing system. It may include an integrated display or be intended to wirelessly transmit images to a computer or portable computer device with dedicated, equipment specific, ultrasound imaging software installed, that is supplied as an integral component of the device.
Access comprehensive regulatory information for Portable Ultrasound Scanner - 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 Sonostar Technologies Co Limited in China. The device registration started on April 07, 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.