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Mechatronic external knee prosthesis - ARTG 463488

Access comprehensive regulatory information for Mechatronic external knee prosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 463488 and sponsored by Ossur Australia Pty Ltd, manufactured by College Park Industries Inc in United States of America. The device registration started on October 02, 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 463488
Class I
Mechatronic external knee prosthesis
ARTG ID: 463488
Good Name: Ossur Australia Pty Ltd - Mechatronic external knee prosthesis
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Intended Purpose

The product is intended for transfemoral amputees as a prosthetic medical device designed to restore some function of an anatomical knee joint

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
463488
Start Date
October 02, 2024
Effective Date
October 02, 2024
Manufacturer
Country
United States of America
Address
27955 College Park Drive, Warren, MI, 48088-4877