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Hepatic ultrasound elastography applicator

Access comprehensive regulatory information for Hepatic ultrasound elastography applicator in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by GE Healthcare Australia Pty Ltd, manufactured by Echosens in France. The device registration started on April 24, 2017.

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
Hepatic ultrasound elastography applicator
Australia TGA ARTG Registered Device
Good Name: GE Healthcare Australia Pty Ltd - Hepatic ultrasound elastography applicator
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Intended Purpose

This device is a hepatic ultrasound elastography applicator designed to be used for the transcutaneous measurement of liver stiffness based on transient elastography. It includes an ultrasound transducer and an electrodynamic transducer intended to generate a controlled transient vibration that produces a mechanical elastic shear wave propagated through the skin and liver; subsequent ultrasound measurements can be used to calculate a measure of liver stiffness.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
April 24, 2017
Effective Date
April 24, 2017
Manufacturer
Country
France
Address
30 place d'Italie, Paris, 75013