Australia TGA ARTG record

Pulse oximeter, battery-powered

Australia TGA ARTG Registered Device · TLC Diagnostics Pty Ltd · Xuzhou Yongkang Electronic Science Technology Co Ltd · Class IIb · Started August 07, 2020

Good Name: TLC Diagnostics Pty Ltd - Pulse oximeter, battery-powered

Device classification

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

Registration information

Start Date: August 07, 2020
Effective Date: August 07, 2020

Sponsor

Name: TLC Diagnostics Pty Ltd

Manufacturer

Name: Xuzhou Yongkang Electronic Science Technology Co Ltd
Country: China
Address: 4F Building C8 40 Jiangshan Road Economic and Technological Development Zone, Xuzhou, 221000

Intended purpose

This device is used to provide various non-invasive measurements such as Blood Oxygen Saturation (SpO2), and Heart Rate (BPM).

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 IIb is sponsored by TLC Diagnostics Pty Ltd, manufactured by Xuzhou Yongkang Electronic Science Technology Co Ltd in China. The device registration started on August 07, 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.