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Foetal Doppler system

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 sponsored by YES Medical, manufactured by Bistos Co Ltd in South Korea. The device registration started on July 29, 2021.

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
Class IIa
Foetal Doppler system
Australia TGA ARTG Registered Device
Good Name: YES Medical - Foetal Doppler system
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Intended Purpose

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

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 29, 2021
Effective Date
July 29, 2021
Sponsor
Manufacturer
Country
South Korea
Address
7th Fl A Bldg Woolim Lions Valley 5-cha 302 Galmachi-ro Jungwon-gu Seongnam-si, Gyeonggi-do