Australia TGA ARTG record

Thermometer, infrared, skin

Australia TGA ARTG Registered Device · MAZZEO INTERNATIONAL PTY LTD · Hangzhou Universal Electronic Co Ltd · Class IIa · Started April 29, 2020

Good Name: MAZZEO INTERNATIONAL PTY LTD - Thermometer, infrared, skin

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: April 29, 2020
Effective Date: April 29, 2020

Sponsor

Name: MAZZEO INTERNATIONAL PTY LTD

Manufacturer

Name: Hangzhou Universal Electronic Co Ltd
Country: China
Address: 298 Yunxi Road Cangqian Street, ., Yuhang District Hangzhou, Zhejiang, 311121

Intended purpose

A measuring device for determining the patient's body temperature. It is used to estimate the temperature of a site on the skin, e.g. axilla or forehead by measurement of body infrared emissions at this particular point.

About this record

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 sponsored by MAZZEO INTERNATIONAL PTY LTD, manufactured by Hangzhou Universal Electronic Co Ltd in China. The device registration started on April 29, 2020.

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.