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Mask, surgical, single use

Access comprehensive regulatory information for Mask, surgical, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Avacare Australia Pty Ltd, manufactured by DemeTech Corporation in United States of America. The device registration started on December 16, 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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TGA ARTG Official Data
Class I
Class I
Mask, surgical, single use
Australia TGA ARTG Registered Device
Good Name: Avacare Australia Pty Ltd - Mask, surgical, single use
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Intended Purpose

Intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. Intended for use in infection control practices to reduce the potential exposure to blood and body fluids.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
December 16, 2020
Effective Date
December 16, 2020
Manufacturer
Country
United States of America
Address
14175 NW 60th Avenue, Miami, FL, 33014