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Pulse oximeter, battery-powered - ARTG 388198

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 388198 and sponsored by Brand Merchant Pty Ltd, manufactured by Beijing Choice Electronic Technology Co Ltd in China. The device registration started on May 09, 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.

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TGA ARTG Official Data
Class IIa
ARTG 388198
Class IIa
Pulse oximeter, battery-powered
ARTG ID: 388198
Good Name: Brand Merchant Pty Ltd - Pulse oximeter, battery-powered
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DJ Fang

DJ Fang

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Intended Purpose

A portable, battery powered pulse oximeter that works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2 which is what the oximeter displays as a reading. The oximeter also displays other parameters such as pulse rate and Perfusion Index.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
388198
Start Date
May 09, 2022
Effective Date
May 09, 2022
Manufacturer
Country
China
Address
2nd Floor 3rd Floor and Room 410-412 4th Floor No 2 Building 9 Shuangyuan Road, Shijingshan District, Beijing, 100041