Australia TGA ARTG record

Pulse oximeter, battery-powered

Australia TGA ARTG Registered Device · AA-Med Pty Ltd · Medisana GmbH · Class IIa · Started August 06, 2020

Good Name: AA-Med Pty Ltd - Pulse oximeter, battery-powered

Device classification

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

Registration information

Start Date: August 06, 2020
Effective Date: August 06, 2020

Sponsor

Name: AA-Med Pty Ltd

Manufacturer

Name: Medisana GmbH
Country: Germany
Address: Jagenbergstrasse 19, Neuss, 41468

Intended purpose

The PM 100 Connect pulse oximeter is a portable non-invasive device intended for spot-checking of oxygen saturation of arterial haemoglobin(SpO2) and pulse rate of adult and paediatric patients.

About this record

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 sponsored by AA-Med Pty Ltd, manufactured by Medisana GmbH in Germany. The device registration started on August 06, 2020.

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.