Australia TGA ARTG record

Pulse oximeter, battery-powered

Australia TGA ARTG Registered Device · Ironbark Creek Investments · Guangdong Biolight Meditech Co Ltd · Class IIa · Started September 01, 2021

Good Name: Ironbark Creek Investments - Pulse oximeter, battery-powered

Device classification

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

Registration information

Start Date: September 01, 2021
Effective Date: September 01, 2021

Sponsor

Name: Ironbark Creek Investments

Manufacturer

Name: Guangdong Biolight Meditech Co Ltd
Country: China
Address: No 2 Innovation First Road Technical Innovation Coast Hi-tech Zone, Zhuhai, Guangdong, 519085

Intended purpose

Intended to measure functional arterial oxygen saturation (SpO2) and pulse rate of adult, paediatric and adolescent patients in hospital, hospital type facilities, as well as in the home care environment.

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 Ironbark Creek Investments, manufactured by Guangdong Biolight Meditech Co Ltd in China. The device registration started on September 01, 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.