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Foetal Doppler system - ARTG 321668

Access comprehensive regulatory information for Foetal Doppler system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 321668 and sponsored by Ebos Group Australia Pty Ltd, manufactured by Bistos Co Ltd in South Korea. The device registration started on August 12, 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 321668
Class IIa
Foetal Doppler system
ARTG ID: 321668
Good Name: Ebos Group Australia Pty Ltd - Foetal Doppler system
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Intended Purpose

A hand-held, battery-powered device consisting of a measuring and display unit and probe designed to detect foetal heart beats using ultrasound/Doppler technology with monochrome display.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
321668
Start Date
August 12, 2019
Effective Date
August 12, 2019
Manufacturer
Country
South Korea
Address
7th Fl A Bldg Woolim Lions Valley 5-cha 302 Galmachi-ro Jungwon-gu Seongnam-si, Gyeonggi-do