Australia TGA ARTG record

Ultrasound System Sonon (300L and 300C) - Ultrasound system, imaging, general-purpose

Australia TGA ARTG Registered Device · Limbs & Things Australia Pty Ltd · Healcerion Co Ltd · Class IIa · Started August 30, 2018

Good Name: Limbs & Things Australia Pty Ltd - Ultrasound System Sonon (300L and 300C) - Ultrasound system, imaging, general-purpose

Device classification

Risk Class: Class IIa
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: August 30, 2018
Effective Date: August 30, 2018

Sponsor

Name: Limbs & Things Australia Pty Ltd

Manufacturer

Name: Healcerion Co Ltd
Country: North Korea
Address: 804 ho 38-21 Digital-ro 31 Gil, Guro-gu, Seoul, 08376

Intended purpose

For the use in general purpose ultrasonic scanning through sound waves to provide two dimensional images of most soft tissues. Data and images captured to be analysed and interpreted by a qualified healthcare professional.

About this record

Access comprehensive regulatory information for Ultrasound System Sonon (300L and 300C) - 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 Limbs & Things Australia Pty Ltd, manufactured by Healcerion Co Ltd in North Korea. The device registration started on August 30, 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.