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Prosthesis, external, leg, component, liner - ARTG 421978

Access comprehensive regulatory information for Prosthesis, external, leg, component, liner in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 421978 and sponsored by Massons Healthcare, manufactured by WillowWood Global LLC in United States of America. The device registration started on September 18, 2023.

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 421978
Class I
Prosthesis, external, leg, component, liner
ARTG ID: 421978
Good Name: Massons Healthcare - Prosthesis, external, leg, component, liner
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Intended Purpose

A flexible device designed to be fitted inside the socket of an external upper or lower limb prosthesis to form an interface between the socket and the residual limb; it is intended to enable the residual limb to optimally fit the socket by coupling the two together mechanically and/or by pressure differential. It may be made of various textile or synthetic polymer materials (e.g., silicone, thermoplastic elastomer, polyurethane).

Device Classification
Risk Class
Class I
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
421978
Start Date
September 18, 2023
Effective Date
September 18, 2023
Manufacturer
Country
United States of America
Address
15541 Scioto Darby Road, Mount Sterling, Ohio, 43113