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Pulse oximeter, battery-powered - ARTG 353633

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 353633 and sponsored by Enurse Pty Ltd, manufactured by Beijing Choice Electronic Technology Co Ltd in China. The device registration started on January 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.

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TGA ARTG Official Data
Class IIa
ARTG 353633
Class IIa
Pulse oximeter, battery-powered
ARTG ID: 353633
Good Name: Enurse Pty Ltd - Pulse oximeter, battery-powered
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Intended Purpose

The fingertip pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2)and Pulse Rate of adult, adolescent and child patients in hospitals, hospital-type facilities and homecare

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
353633
Start Date
January 27, 2021
Effective Date
January 27, 2021
Sponsor
Manufacturer
Country
China
Address
2nd Floor 3rd Floor and Room 410-412 4th Floor No 2 Building 9 Shuangyuan Road, Shijingshan District, Beijing, 100041