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Pulse oximeter, battery-powered - ARTG 380832

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 380832 and sponsored by HealthBeats Pty Ltd, manufactured by Shenzhen Jumper Medical Equipment Co Ltd in China. The device registration started on December 14, 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 380832
Class IIa
Pulse oximeter, battery-powered
ARTG ID: 380832
Good Name: HealthBeats Pty Ltd - Pulse oximeter, battery-powered
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DJ Fang

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Intended Purpose

This fingertip pulse oximeter is a non-invasive device intended for spotchecking of functional oxygen saturation of arterial haemoglobin and pulse rate. The portable fingertip device is indicated for adult and paediatric patients in home and hospital environments

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
380832
Start Date
December 14, 2021
Effective Date
December 14, 2021
Manufacturer
Country
China
Address
D Building No 71 Xintian Road Fuyong Street Baoan, Shenzhen, Guangdong, 518103