Australia TGA ARTG record

Pulse oximeter, battery-powered

Australia TGA ARTG Registered Device · Genesis Biotech Pty Ltd · Shenzhen Creative Industry Co Ltd · Class IIa · Started August 27, 2021

Good Name: Genesis Biotech Pty Ltd - Pulse oximeter, battery-powered

Device classification

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

Registration information

Start Date: August 27, 2021
Effective Date: August 27, 2021

Sponsor

Name: Genesis Biotech Pty Ltd

Manufacturer

Name: Shenzhen Creative Industry Co Ltd
Country: China
Address: Floor 5 BLD 9 BaiWangxin High-Tech Industrial Park Songbai Road Xili Street, Nanshan District, Shenzhen, 518110

Intended purpose

Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO 2 ) through a patient’s finger. It is applicable for checking SpO2 and pulse rate of adult and paediatric patients in homes and medical clinics.

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 Genesis Biotech Pty Ltd, manufactured by Shenzhen Creative Industry Co Ltd in China. The device registration started on August 27, 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.