Pure Global

Telemetric diagnostic spirometer

Access comprehensive regulatory information for Telemetric diagnostic spirometer in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by MGC Diagnostics Australia Pty Ltd, manufactured by Ganshorn Medizin Electronic GmbH in Germany. The device registration started on April 30, 2020.

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 IIa
Class IIa
Telemetric diagnostic spirometer
Australia TGA ARTG Registered Device
Good Name: MGC Diagnostics Australia Pty Ltd - Telemetric diagnostic spirometer
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Intended Purpose

This device is intended to be used by adults and children over 5 years old in physician's offices, clinics and home settings to conduct basic lung function and spirometry testing. The results can be streamed to smartphones, tablets, computer systems and specific Clinics and Clinicians.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
April 30, 2020
Effective Date
April 30, 2020
Manufacturer
Country
Germany
Address
Industriestrasse 6-8, Niederlauer, 97618