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Nitric oxide breath analyser

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.

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Class Im
Class Im
Nitric oxide breath analyser
Australia TGA ARTG Registered Device
Good Name: Innervate Pty Ltd - Nitric oxide breath analyser
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Intended Purpose

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

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
Manufacturer
Country
United Kingdom
Address
Station Road Harrietsham Maidstone, Kent, ME17 1JA