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Ultrasound system, imaging, general-purpose - ARTG 407994

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 registered under ARTG number 407994 and sponsored by Visionflex Pty Ltd, manufactured by Healcerion Co Ltd in South Korea. The device registration started on April 24, 2023.

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
ARTG 407994
Class IIa
Ultrasound system, imaging, general-purpose
ARTG ID: 407994
Good Name: Visionflex Pty Ltd - Ultrasound system, imaging, general-purpose
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Intended Purpose

The SONON ultrasound device is a portable ultrasound scanner intended for use in professional healthcare environments, to obtain ultrasound echo images that can be used for clinical diagnostic purposes.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
407994
Start Date
April 24, 2023
Effective Date
April 24, 2023
Manufacturer
Country
South Korea
Address
501ho 11 Gasan digital 2-ro Geumcheon-gu, Seoul, 08593