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Hyperthermia system, ultrasound - ARTG 260438

Access comprehensive regulatory information for Hyperthermia system, ultrasound in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 260438 and sponsored by Getz Healthcare Pty Ltd, manufactured by InSightec Ltd in Israel. The device registration started on September 30, 2015.

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 IIb
ARTG 260438
Class IIb
Hyperthermia system, ultrasound
ARTG ID: 260438
Good Name: Getz Healthcare Pty Ltd - Hyperthermia system, ultrasound
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Intended Purpose

to produce and control the delivery of high heat, i.e. temperatures greater than 43 degrees Celsius, to the body for the treatment of malignant or benign tumours, or other disease conditions. It is capable of producing whole body or localized heating effects within tissue or organs using an ultrasonic energy source.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
260438
Start Date
September 30, 2015
Effective Date
September 30, 2015
Manufacturer
Country
Israel
Address
5 Nachum Heth St, PO BOX 2059, Tirat Carmel, 39120