Australia TGA ARTG record

Valve, pulmonary function

Australia TGA ARTG Registered Device · MGC Diagnostics Australia Pty Ltd · Hans Rudolph Inc · Class IIa · Started June 08, 2021

Good Name: MGC Diagnostics Australia Pty Ltd - Valve, pulmonary function

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

Sponsor

Name: MGC Diagnostics Australia Pty Ltd

Manufacturer

Name: Hans Rudolph Inc
Country: United States of America
Address: 8325 Cole Parkway, Shawnee, KS, 66227

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.

About this record

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.