Australia TGA ARTG record

Thermometer, infrared, skin

Australia TGA ARTG Registered Device · PUREGIENE AUSTRALASIA · Shenzhen LEPU Intelligent Medical Equipment Co Ltd · Class IIa · Started November 26, 2020

Good Name: PUREGIENE AUSTRALASIA - Thermometer, infrared, skin

Device classification

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

Registration information

Start Date: November 26, 2020
Effective Date: November 26, 2020

Sponsor

Name: PUREGIENE AUSTRALASIA

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

Digital thermometer used to estimate the temperature of a site on the skin by measurement of 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 PUREGIENE AUSTRALASIA, manufactured by Shenzhen LEPU Intelligent Medical Equipment Co Ltd in China. The device registration started on November 26, 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.