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Wrist OX2 Model 3150 with USB - Pulse oximeter, battery-powered

Access comprehensive regulatory information for Wrist OX2 Model 3150 with USB - 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 Temple Healthcare Pty Ltd, manufactured by Nonin Medical Inc in United States of America. The device registration started on August 28, 2019.

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
Wrist OX2 Model 3150 with USB - Pulse oximeter, battery-powered
Australia TGA ARTG Registered Device
Good Name: Temple Healthcare Pty Ltd - Wrist OX2 Model 3150 with USB - Pulse oximeter, battery-powered
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Intended Purpose

A small, lightweight, portable device indicated for use in measuring and displaying functional oxygen saturation of arterial haemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. The display is worn on the wrist and can be used for long term recording.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
August 28, 2019
Effective Date
August 28, 2019
Manufacturer
Country
United States of America
Address
13700 1st Avenue North, Plymouth, MN, 55441-5443