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Infrared patient thermometer, ear/skin - ARTG 399330

Access comprehensive regulatory information for Infrared patient thermometer, ear/skin in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 399330 and sponsored by Kalyan Industries Pty Ltd, manufactured by Shenzhen Urion Technology Co Ltd in China. The device registration started on November 11, 2022.

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 399330
Class IIa
Infrared patient thermometer, ear/skin
ARTG ID: 399330
Good Name: Kalyan Industries Pty Ltd - Infrared patient thermometer, ear/skin
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Intended Purpose

The Infrared Thermometer is intended primarily for the measurement of human body temperature of the skin surface at the location of the external ear and forehead. The Infrared Thermometer is also intended to measure ambient temperature. The device is indicated for use by people of all ages at home care and in hospital.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
399330
Start Date
November 11, 2022
Effective Date
November 11, 2022
Manufacturer
Country
China
Address
Floor 4-6th of Building D Jiale Science & Technology Industrial Zone, No 3 ChangWei Road Heshuikou Community MaTian Street, GuangMing New District, Shenzhen, 518106