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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 NDD Medizintechnik AG in Switzerland. The device registration started on November 06, 2023.

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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TGA ARTG Official Data
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

The EasyOne FlowTube and EasyOne Spirette are dedicated Mouthpieces designed specifically for EasyOne Spirometers and EasyOne Pulmonary Function Testing Devices. The EasyOne FlowTube and the EasyOne Spirette contain Bacterial and Viral Filter Membranes which have been tested by independent laboratories and are proven to protect the EasyOne range of Spirometers from cross-contamination. The EasyOne FlowTube and EasyOne Spirette are single-patient use.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
November 06, 2023
Effective Date
November 06, 2023
Manufacturer
Country
Switzerland
Address
Technoparkstrasse 1, ZURICH, CH-8005