Australia flagARTG 451705

Oxygen/air/nitrous oxide breathing gas mixer

ARTG ID: 451705 · Tenacore Pty Ltd · DEHAS Medical Systems GmbH · Class IIb · Started June 11, 2024

Good Name: Tenacore 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
ARTG ID
451705
Start Date
June 11, 2024
Effective Date
June 11, 2024
Sponsor
Manufacturer
Country
Germany
Address
Wesloer Str 107-109, Lubeck, 23568
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).

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 registered under ARTG number 451705 and 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.

Free DatabasePowered by Pure Global AITGA ARTG Official Data