Australia TGA ARTG record

Pulse oximeter, battery-powered

Australia TGA ARTG Registered Device · Health One Pty Ltd · Shenzhen IMDK Medical Technology Co Ltd · Class IIa · Started December 16, 2021

Good Name: Health One Pty Ltd - Pulse oximeter, battery-powered

Device classification

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

Registration information

Start Date: December 16, 2021
Effective Date: December 16, 2021

Sponsor

Name: Health One Pty Ltd

Manufacturer

Name: Shenzhen IMDK Medical Technology Co Ltd
Country: China
Address: C zone 10F Building 16 Yuanshan Industrial B Area Gongming Street, Guangming district, Shenzhen, 518106

Intended purpose

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).

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 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.