Australia TGA ARTG record

Probe, pulse oximeter, single use

Australia TGA ARTG Registered Device · Natus Medical Pty Ltd · Nonin Medical Inc · Class IIb · Started November 10, 2023

Good Name: Natus Medical Pty Ltd - Probe, pulse oximeter, single use

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: November 10, 2023
Effective Date: November 10, 2023

Sponsor

Name: Natus Medical Pty Ltd

Manufacturer

Name: Nonin Medical Inc
Country: United States of America
Address: 13700 1st Avenue North, Plymouth, MN, 55441-5443

Intended purpose

31658 - Pulse oximeter probe, single-use A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of hemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. This is a single-use device.

About this record

Access comprehensive regulatory information for Probe, pulse oximeter, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Natus Medical Pty Ltd, manufactured by Nonin Medical Inc in United States of America. The device registration started on November 10, 2023.

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.