Pure Global

Thermometer, infrared, skin

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIa
Class IIa
Thermometer, infrared, skin
Australia TGA ARTG Registered Device
Good Name: Genesis Biotech Pty Ltd - Thermometer, infrared, skin
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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

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
Manufacturer
Country
China
Address
North Side of Flr 3 BLD9 BaiWingxin High-Tech Industrial Park Songbai Rd Xili St, Nanshan District Shenzhen, Guangdong, 518055