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Mask strap

Access comprehensive regulatory information for Mask strap in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Intersurgical Australia Pty Ltd, manufactured by Pulmodyne Inc in United States of America. The device registration started on December 15, 2021.

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 I
Class I
Mask strap
Australia TGA ARTG Registered Device
Good Name: Intersurgical Australia Pty Ltd - Mask strap
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Intended Purpose

A head strap used to hold and stabilise a CPAP or BIPAP face mask onto a patient's face.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
December 15, 2021
Effective Date
December 15, 2021
Manufacturer
Country
United States of America
Address
2055 Executive Drive, Indianapolis, IN, 46241