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Oxygen/air/nitrous oxide breathing gas mixer

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 Tenacore Pty Ltd, manufactured by DEHAS Medical Systems GmbH in Germany. The device registration started on June 11, 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.

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TGA ARTG Official Data
Class IIb
Class IIb
Oxygen/air/nitrous oxide breathing gas mixer
Australia TGA ARTG Registered Device
Good Name: Tenacore Pty Ltd - Oxygen/air/nitrous oxide breathing gas mixer
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Intended Purpose

The QualityMix N2O oxygen/nitrous oxide mixer is designed for the administration of a continuous and accurate mixture of medical nitrous oxide and medical oxygen to infants, children and adults via the exit port. The exact fractionated inspiratory oxygen nitrous oxide concentration (FIO2/FIN2O) corresponds to the selected FIO2/FIN2O setting on the control knob (rotary selector).

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
June 11, 2024
Effective Date
June 11, 2024
Sponsor
Manufacturer
Country
Germany
Address
Wesloer Str 107-109, Lubeck, 23568