Australia TGA ARTG record

Pulse oximeter, battery-powered

Australia TGA ARTG Registered Device · Digital Sleep Devices Pty Ltd · Contec Medical Systems Co Ltd · Class IIa · Started March 13, 2024

Good Name: Digital Sleep Devices Pty Ltd - Pulse oximeter, battery-powered

Device classification

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

Registration information

Start Date: March 13, 2024
Effective Date: March 13, 2024

Sponsor

Name: Digital Sleep Devices Pty Ltd

Manufacturer

Name: Contec Medical Systems Co Ltd
Country: China
Address: No 112 Qinhuang West Street Economic & Technical Development Zone, Qinhuangdao, Hebei Province, 066004

Intended purpose

This is a portable device that is intended to be used to measure the saturation of oxygen carried in red blood cells the transcutaneous measurement. The display of haemoglobin oxygen saturation (SpO2)in a human body is obtained.

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 Digital Sleep Devices Pty Ltd, manufactured by Contec Medical Systems Co Ltd in China. The device registration started on March 13, 2024.

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.