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Foetal Doppler system probe - ARTG 337491

Access comprehensive regulatory information for Foetal Doppler system probe in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 337491 and sponsored by Australia Medical Alliance Services Pty Ltd T/As AMA Medical Products, manufactured by Edan Instruments Inc in China. The device registration started on June 05, 2020.

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 337491
Class IIa
Foetal Doppler system probe
ARTG ID: 337491
Good Name: AMA Services WA Pty Ltd T/A AMA Medical Products - Foetal Doppler system probe
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Intended Purpose

The Probes are for use with the EDAN range of handheld Dopplers which are intended for use by qualified healthcare practitioners in primary, acute and community healthcare environments, for the assessment of fetal heart rate.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
337491
Start Date
June 05, 2020
Effective Date
June 05, 2020
Manufacturer
Country
China
Address
#15 Jinhui Road Jinsha Community Kengzi Sub-District Pingshan District, Shenzhen, 518122