Pure Global

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 The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia, manufactured by Guangdong Biolight Meditech Co Ltd in China. The device registration started on December 06, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIa
Class IIa
Pulse oximeter, battery-powered
Australia TGA ARTG Registered Device
Good Name: The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia - Pulse oximeter, battery-powered
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

A small and easily portable device that measures the blood oxygen saturation of a patient (SPO2), be they adult or paediatric. The device is battery powered by AAA batteries and functions by using signals generated by LEDโ€™s, and received by photoelectric receiver and displays these signals for interpretation on a small in-built screen. This device is capable of monitoring SPO2, Pulse rate and plethysmograph. The device is typically applied to the fingertip or around the wrist; it is broadly used, however most commonly by end users for quick "spot checks" of the SPO2 reading. However the device can be used in a hospital, clinic or Emergency services setting.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
December 06, 2021
Effective Date
December 06, 2021
Manufacturer
Country
China
Address
No 2 Innovation First Road Technical Innovation Coast Hi-tech Zone, Zhuhai, Guangdong, 519085