Australia TGA ARTG record

Pulse oximeter, battery-powered

Australia TGA ARTG Registered Device · Tempo Australia Pty Ltd · Shanghai Berry Electronic Tech Co Ltd · Class IIb · Started August 30, 2022

Good Name: Tempo Australia Pty Ltd - Pulse oximeter, battery-powered

Device classification

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

Registration information

Start Date: August 30, 2022
Effective Date: August 30, 2022

Sponsor

Name: Tempo Australia Pty Ltd

Manufacturer

Name: Shanghai Berry Electronic Tech Co Ltd
Country: China
Address: Unit 104 1st Floor 7th Building No 1188 Lianhang Road, Minhang District, Shanghai, 201112

Intended purpose

this device is used to monitor the physiological signal, included. arterial oxygen saturation sp02 and pulse rate (PR) by clipping the device to the finger. The device measures these physiological signs(sp02 and PR) of clients then the numerical results are displayed on the screen. The device is used for regular monitoring purposes in aged care, retirement villages, and homes. The device is not intended for diagnostic purposes.

About this record

Access comprehensive regulatory information for Pulse oximeter, battery-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Tempo Australia Pty Ltd, manufactured by Shanghai Berry Electronic Tech Co Ltd in China. The device registration started on August 30, 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.