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

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.

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Class IIa
Class IIa
Ultrasound System Sonon (300L and 300C) - Ultrasound system, imaging, general-purpose
Australia TGA ARTG Registered Device
Good Name: Limbs & Things Australia Pty Ltd - Ultrasound System Sonon (300L and 300C) - Ultrasound system, imaging, general-purpose
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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.

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
Manufacturer
Country
North Korea
Address
804 ho 38-21 Digital-ro 31 Gil, Guro-gu, Seoul, 08376