Australia TGA ARTG record

Nitric oxide breath analyser

Australia TGA ARTG Registered Device · Innervate Pty Ltd · Bedfont Scientific Limited · Class Im · Started October 25, 2022

Good Name: Innervate Pty Ltd - Nitric oxide breath analyser

Device classification

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

Registration information

Start Date: October 25, 2022
Effective Date: October 25, 2022

Sponsor

Name: Innervate Pty Ltd

Manufacturer

Name: Bedfont Scientific Limited
Country: United Kingdom
Address: Station Road Harrietsham Maidstone, Kent, ME17 1JA

Intended purpose

The NO Breath measures FeNO (Fractional Exhaled Nitric Oxide) in Human Breath.

About this record

Access comprehensive regulatory information for Nitric oxide breath analyser in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Im is sponsored by Innervate Pty Ltd, manufactured by Bedfont Scientific Limited in United Kingdom. The device registration started on October 25, 2022.

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.