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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 Shenzhen Narig Bio-Medical Technology Co Ltd in China. The device registration started on May 30, 2023.

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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TGA ARTG Official Data
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 pulse oximeter is intended to be used for noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric (โ‰ฅ10Kg) patients during both no motion and motion conditions, and for patients who are well or poorly perfused.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 30, 2023
Effective Date
May 30, 2023
Manufacturer
Country
China
Address
1106 Room East Tower Digital Culture Industry Base, No 10128 Shennan Road Nanshan District Shenzhen City, Guangdong, 518052