Australia TGA ARTG record

Thermometer, infrared, skin

Australia TGA ARTG Registered Device · Genesis Biotech Pty Ltd · Shenzhen LEPU Intelligent Medical Equipment Co Ltd · Class IIa · Started September 10, 2021

Good Name: Genesis Biotech Pty Ltd - Thermometer, infrared, skin

Device classification

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

Registration information

Start Date: September 10, 2021
Effective Date: September 10, 2021

Sponsor

Name: Genesis Biotech Pty Ltd

Manufacturer

Name: Shenzhen LEPU Intelligent Medical Equipment Co Ltd
Country: China
Address: North Side of Flr 3 BLD9 BaiWingxin High-Tech Industrial Park Songbai Rd Xili St, Nanshan District Shenzhen, Guangdong, 518055

Intended purpose

Battery operated infrared thermometer intended to be for the measurement and monitoring of human body temperature from forehead. The device is indicated for use by people of all ages at homecare and in hospital

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 Genesis Biotech Pty Ltd, manufactured by Shenzhen LEPU Intelligent Medical Equipment Co Ltd in China. The device registration started on September 10, 2021.

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.