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Pulse oximeter, battery-powered

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.

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Class IIa
Class IIa
Pulse oximeter, battery-powered
Australia TGA ARTG Registered Device
Good Name: Respirtec Corporation - Pulse oximeter, battery-powered
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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.

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
Manufacturer
Country
China
Address
Unit 104 1st Floor 7th Building No 1188 Lianhang Road, Minhang District, Shanghai, 201112