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Valve, pulmonary function

Access comprehensive regulatory information for Valve, pulmonary function 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 Hans Rudolph Inc in United States of America. The device registration started on June 08, 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 IIa
Class IIa
Valve, pulmonary function
Australia TGA ARTG Registered Device
Good Name: MGC Diagnostics Australia Pty Ltd - Valve, pulmonary function
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Intended Purpose

Two-Way non-rebreathing valves are intended for use as a component of a respiratory circuit for spontaneously breathing patients to enable two-way non-rebreathing. The direction of flow through the valve is indicated with arrows marked on the valve body. These valves are indicated for use in pulmonary function testing, exercise testing, and respiratory research and custom applications involving adults and paediatric patients. These Valves are not intended for use involving critical care or life support, ventilation or anaesthesia.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
June 08, 2021
Effective Date
June 08, 2021
Manufacturer
Country
United States of America
Address
8325 Cole Parkway, Shawnee, KS, 66227