Australia TGA ARTG record

Oxygen/air/nitrous oxide breathing gas mixer

Australia TGA ARTG Registered Device · Durr Dental Oceania Pty Ltd · Baldus Sedation GmbH & Co KG · Class IIb · Started May 08, 2024

Good Name: Durr Dental Oceania Pty Ltd - Oxygen/air/nitrous oxide breathing gas mixer

Device classification

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

Registration information

Start Date: May 08, 2024
Effective Date: May 08, 2024

Sponsor

Name: Durr Dental Oceania Pty Ltd

Manufacturer

Name: Baldus Sedation GmbH & Co KG
Country: Germany
Address: In der Langfuhr 32, Bendorf, 56170

Intended purpose

Indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen to a conscious, spontaneously breathing patient.”

About this record

Access comprehensive regulatory information for Oxygen/air/nitrous oxide breathing gas mixer in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Durr Dental Oceania Pty Ltd, manufactured by Baldus Sedation GmbH & Co KG in Germany. The device registration started on May 08, 2024.

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.