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Pulmonary function testing filter/mouthpiece - ARTG 388664

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 388664 and sponsored by Innervate Pty Ltd, manufactured by NDD Medizintechnik AG in Switzerland. The device registration started on May 18, 2022.

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 388664
Class I
Pulmonary function testing filter/mouthpiece
ARTG ID: 388664
Good Name: Innervate Pty Ltd - Pulmonary function testing filter/mouthpiece
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Intended Purpose

The EasyOne Filter is intended to be used in combination with NDD breathing mouthpieces (i.e. Spirettes and FlowTubes) to reduce bacteria, viruses and other particulates from the patient's exhaled air while performing flow measurements, such as Spirometry tests. The EasyOne Filter connects directly to the Distal End of the ndd Spirette or ndd FlowTube. The EasyOne Filter is a single-use device and is intended for single-patient use only.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
388664
Start Date
May 18, 2022
Effective Date
May 18, 2022
Manufacturer
Country
Switzerland
Address
Technoparkstrasse 1, ZURICH, CH-8005