Australia TGA ARTG record

Anaesthesia breathing circuit, reusable

Australia TGA ARTG Registered Device · Durr Dental Oceania Pty Ltd · Baldus Sedation GmbH & Co KG · Class IIa · Started July 26, 2024

Good Name: Durr Dental Oceania Pty Ltd - Anaesthesia breathing circuit, reusable

Device classification

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

Registration information

Start Date: July 26, 2024
Effective Date: July 26, 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

This is a anesthesia breathing circuit that is intended to be used within dentistry with nitrous oxide. Due to the exhalation in the inner mask, the membrane opens and the exhaled gas enters the outer mask. The suction in the outer mask is separate from the inner mask, so the patient can breathe without resistance.

About this record

Access comprehensive regulatory information for Anaesthesia breathing circuit, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Durr Dental Oceania Pty Ltd, manufactured by Baldus Sedation GmbH & Co KG in Germany. The device registration started on July 26, 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.