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Pulmonary function testing filter/mouthpiece

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.

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Class IIa
Class IIa
Pulmonary function testing filter/mouthpiece
Australia TGA ARTG Registered Device
Good Name: Innervate Pty Ltd - Pulmonary function testing filter/mouthpiece
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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.

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
Manufacturer
Country
United Kingdom
Address
NFC House Vickers Industrial Estate Mellishaw Lane, Morecambe, Lancashire, LA3 3EN