Australia TGA ARTG record

Pulse oximeter, battery-powered

Australia TGA ARTG Registered Device · Respirtec Corporation · Shanghai Berry Electronic Tech Co Ltd · Class IIa · Started May 16, 2022

Good Name: Respirtec Corporation - Pulse oximeter, battery-powered

Device classification

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

Registration information

Start Date: May 16, 2022
Effective Date: May 16, 2022

Sponsor

Name: Respirtec Corporation

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

An electronic photoelectric device designed to measure and display haemoglobin oxygen saturation.LED signals are produced and received by a photodetector, and may also display pulse rate. It is applied to finger or wrist, may be single or multiple components, and may wirelessly transmit measurements. Intended for use by laypersons or healthcare providers.

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 IIa is sponsored by Respirtec Corporation, manufactured by Shanghai Berry Electronic Tech Co Ltd in China. The device registration started on May 16, 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.