Pulse oximeter, battery-powered - ARTG 380968
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 registered under ARTG number 380968 and sponsored by Health One Pty Ltd, manufactured by Shenzhen IMDK Medical Technology Co Ltd in China. The device registration started on December 16, 2021.
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.
This is a portable battery powered device intended to provide non-invasive intermittent measurement of oxygen saturation (SpO2) of haemoglobin, the heart rate (PRbpm) and the perfusion index (PI). This device is suitable for private use (at home) as well as for use in the healthcare facilities (hospitals, emergency services, medical establishments).