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Medical equipment drape, single-use - ARTG 442971

Access comprehensive regulatory information for Medical equipment drape, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is registered under ARTG number 442971 and sponsored by Endotherapeutics Pty Ltd, manufactured by Advance Medical Designs Inc in United States of America. The device registration started on February 29, 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 Is
ARTG 442971
Class Is
Medical equipment drape, single-use
ARTG ID: 442971
Good Name: Endotherapeutics Pty Ltd - Medical equipment drape, single-use
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Intended Purpose

A sterile drape intended to be used as a protective covering for the Human Xtensions HandX device, to provide a barrier against cross-contamination of the surgical field.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
442971
Start Date
February 29, 2024
Effective Date
February 29, 2024
Manufacturer
Country
United States of America
Address
1241 Atlanta Industrial Drive, Marietta, GEORGIA, 30066