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Gown, isolation, single use - ARTG 464945

Access comprehensive regulatory information for Gown, isolation, single use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 464945 and sponsored by The O R Company Pty Ltd, manufactured by Aspen Surgical Products Inc in United States of America. The device registration started on October 18, 2024.

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
ARTG 464945
Class I
Gown, isolation, single use
ARTG ID: 464945
Good Name: The O R Company Pty Ltd - Gown, isolation, single use
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Intended Purpose

Gowns are physical barrier worn by the healthcare personnel to prevent the transfer of particulate material and microorganisms and bodily fluid

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
464945
Start Date
October 18, 2024
Effective Date
October 18, 2024
Manufacturer
Country
United States of America
Address
6945 Southbelt Drive SE, Caledonia, MI, 49316