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Noninvasive vascular ultrasound system, battery-powered - ARTG 315201

Access comprehensive regulatory information for Noninvasive vascular ultrasound system, battery-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 315201 and sponsored by A Algeo Australia Pty Ltd, manufactured by Bistos Co Ltd in South Korea. The device registration started on March 07, 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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Class IIa
ARTG 315201
Class IIa
Noninvasive vascular ultrasound system, battery-powered
ARTG ID: 315201
Good Name: A Algeo Australia Pty Ltd - Noninvasive vascular ultrasound system, battery-powered
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Intended Purpose

A device assembly consisting of a graphical display unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
315201
Start Date
March 07, 2019
Effective Date
March 07, 2019
Manufacturer
Country
South Korea
Address
7th Fl A Bldg Woolim Lions Valley 5-cha 302 Galmachi-ro Jungwon-gu Seongnam-si, Gyeonggi-do