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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 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.

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TGA ARTG Official Data
Class IIb
Class IIb
Pulse oximeter, battery-powered
Australia TGA ARTG Registered Device
Good Name: TLC Diagnostics Pty Ltd - Pulse oximeter, battery-powered
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Intended Purpose

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

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
Manufacturer
Country
China
Address
4F Building C8 40 Jiangshan Road Economic and Technological Development Zone, Xuzhou, 221000