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
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 451705
- Start Date
- June 11, 2024
- Effective Date
- June 11, 2024
- Name
- Tenacore Pty Ltd
- Country
- Germany
- Address
- Wesloer Str 107-109, Lubeck, 23568
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).
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.