Australia TGA ARTG record

Pulse oximeter, battery-powered

Australia TGA ARTG Registered Device · SaniteX Global Pty Ltd · Shenzhen Witleaf Medical Electronics Co Ltd · Class IIa · Started January 14, 2022

Good Name: SaniteX Global Pty Ltd - Pulse oximeter, battery-powered

Device classification

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

Registration information

Start Date: January 14, 2022
Effective Date: January 14, 2022

Sponsor

Name: SaniteX Global Pty Ltd

Manufacturer

Name: Shenzhen Witleaf Medical Electronics Co Ltd
Country: China
Address: 13/F-B2 Block 1 Senyang Science Park No 7 Road West District of High-Tech Park, Guangming District, Shenzhen, 518132

Intended purpose

This device is battery powered and intended to be used for the non-invasive measurement of oxygen saturation (SpO2)of haemoglobin and heart rate. The device can be used in both home and healthcare environments and is suitable for children and adults.

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 SaniteX Global Pty Ltd, manufactured by Shenzhen Witleaf Medical Electronics Co Ltd in China. The device registration started on January 14, 2022.

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.