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Pulmonary function testing filter/mouthpiece - ARTG 309002

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 I is registered under ARTG number 309002 and sponsored by Innervate Pty Ltd, manufactured by NDD Medizintechnik AG in Switzerland. The device registration started on September 05, 2018.

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 I
ARTG 309002
Class I
Pulmonary function testing filter/mouthpiece
ARTG ID: 309002
Good Name: Innervate Pty Ltd - Pulmonary function testing filter/mouthpiece
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Intended Purpose

A non-sterile, portable, dedicated screening device intended to be used during pulmonary function testing to remove and retain microdroplets from patient breath to reduce contamination of the parent device; it is also intended to function as a mouthpiece to facilitate access to the patient's respiratory tract. It is a bidirectional filter, typically in a plastic housing, with a proximal port/mouthpiece. This is a single patient-use device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
309002
Start Date
September 05, 2018
Effective Date
September 05, 2018
Manufacturer
Country
Switzerland
Address
Technoparkstrasse 1, ZURICH, CH-8005