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Thermometer, infrared, skin - ARTG 177533

Access comprehensive regulatory information for Thermometer, infrared, skin in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 177533 and sponsored by GE Healthcare Australia Pty Ltd, manufactured by Exergen Corporation in United States of America. The device registration started on November 11, 2010.

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
ARTG 177533
Class IIa
Thermometer, infrared, skin
ARTG ID: 177533
Good Name: GE Healthcare Australia Pty Ltd - Thermometer, infrared, skin
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Intended Purpose

This thermometer is intended to be a measuring device for determining the patient's body temperature. This thermometer measures body infrared emissions at a particular point to estimate the temperature of a site on the skin. It requires a battery for operation.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
177533
Start Date
November 11, 2010
Effective Date
November 11, 2010
Manufacturer
Country
United States of America
Address
400 Pleasant Street, WATERTOWN, MAINE, 02472