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Spirometer/pulmonary function analyser syringe - ARTG 357190

Access comprehensive regulatory information for Spirometer/pulmonary function analyser syringe in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 357190 and sponsored by MGC Diagnostics Australia Pty Ltd, manufactured by Hans Rudolph Inc in United States of America. The device registration started on March 22, 2021.

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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TGA ARTG Official Data
Class I
ARTG 357190
Class I
Spirometer/pulmonary function analyser syringe
ARTG ID: 357190
Good Name: MGC Diagnostics Australia Pty Ltd - Spirometer/pulmonary function analyser syringe
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Intended Purpose

This device is designed for testing and calibrating Flow and Volume Measurement Devices by injecting small volumes of gas into a spirometer, pulmonary function analyser, or other diagnostic pulmonary testing device for calibration or reference. This device is used by persons trained in the calibration procedures of the equipment under test. This is a reusable device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
357190
Start Date
March 22, 2021
Effective Date
March 22, 2021
Manufacturer
Country
United States of America
Address
8325 Cole Parkway, Shawnee, KS, 66227