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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 Le Reve HealthCare Pty Ltd (AKA Caremax), manufactured by Shenzhen Jumper Medical Equipment Co Ltd in China. The device registration started on April 23, 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
Class IIa
Foetal Doppler system
Australia TGA ARTG Registered Device
Good Name: Le Reve HealthCare Pty Ltd (AKA Caremax) - Foetal Doppler system
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Intended Purpose

A portable hand-held doppler for the audiable detection of the fetal heartbeat/rate using ultrasound technology. This device is not intended for treatment

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
April 23, 2019
Effective Date
April 23, 2019
Sponsor
Manufacturer
Country
China
Address
D Building No 71 Xintian Road Fuyong Street Baoan, Shenzhen, Guangdong, 518103