Australia TGA ARTG record

Pulmonary function testing filter/mouthpiece

Australia TGA ARTG Registered Device · Innervate Pty Ltd · GVS Filter Technology UK Ltd · Class IIa · Started October 06, 2020

Good Name: Innervate Pty Ltd - Pulmonary function testing filter/mouthpiece

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: October 06, 2020
Effective Date: October 06, 2020

Sponsor

Name: Innervate Pty Ltd

Manufacturer

Name: GVS Filter Technology UK Ltd
Country: United Kingdom
Address: NFC House Vickers Industrial Estate Mellishaw Lane, Morecambe, Lancashire, LA3 3EN

Intended purpose

A non-sterile bacterial/viral filter intended to be used during pulmonary function testing to remove and retain microdroplets from patient breath to prevent contamination of the parent device and the immediate environment. It is also intended to function as a mouthpiece to facilitate access to the patient's respiratory tract. It may have a basic mouthpiece portion capable of being attached to a separate dedicated mouthpiece. This is a single patient-use device.

About this record

Access comprehensive regulatory information for Pulmonary function testing filter/mouthpiece in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Innervate Pty Ltd, manufactured by GVS Filter Technology UK Ltd in United Kingdom. The device registration started on October 06, 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.