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Instrument/analyser IVDs

Access comprehensive regulatory information for Instrument/analyser IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by MGC Diagnostics Australia Pty Ltd, manufactured by Bedfont Scientific Limited in United Kingdom. The device registration started on March 25, 2019.

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 I
Class I
Instrument/analyser IVDs
Australia TGA ARTG Registered Device
Good Name: MGC Diagnostics Australia Pty Ltd - Instrument/analyser IVDs
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Intended Purpose

A hand held instrument intended to be used to measure Nitric Oxide (NO) in expired breath.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
March 25, 2019
Effective Date
March 25, 2019
Manufacturer
Country
United Kingdom
Address
105 Laker Road Rochester Airport Industrial Estate, Rochester, Kent, ME13QX