Pure Global

Pulse oximeter, battery-powered - ARTG 351593

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 351593 and sponsored by Genesis Biotech Pty Ltd, manufactured by Guangdong Biolight Meditech Co Ltd in China. The device registration started on December 10, 2020.

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
ARTG 351593
Class IIa
Pulse oximeter, battery-powered
ARTG ID: 351593
Good Name: Genesis Biotech Pty Ltd - Pulse oximeter, battery-powered
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

The Fingertip Pulse Oximeter is intended to measure functional arterial oxygen saturation (SpO2) and pulse rate of adult patients in hospitals, medical clinics, as well as in the home care environment. The oximeter is not suitable to monitor patient continuously for long term.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
351593
Start Date
December 10, 2020
Effective Date
December 10, 2020
Manufacturer
Country
China
Address
No 2 Innovation First Road Technical Innovation Coast Hi-tech Zone, Zhuhai, Guangdong, 519085