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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 Genesis Biotech Pty Ltd, manufactured by Guangdong Biolight Meditech Co Ltd in China. The device registration started on December 10, 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.

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Class IIa
Class IIa
Pulse oximeter, battery-powered
Australia TGA ARTG Registered Device
Good Name: Genesis Biotech Pty Ltd - Pulse oximeter, battery-powered
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Intended Purpose

The Fingertip Pulse Oximeter is intended to measure functional arterial oxygen saturation (SpO2) and pulse rate of adult patients in hospitals, medical clinics, as well as in the home care environment. The oximeter is not suitable to monitor patient continuously for long term.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
December 10, 2020
Effective Date
December 10, 2020
Manufacturer
Country
China
Address
No 2 Innovation First Road Technical Innovation Coast Hi-tech Zone, Zhuhai, Guangdong, 519085