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Orthosis, leg, ankle/foot, unit - ARTG 442311

Access comprehensive regulatory information for Orthosis, leg, ankle/foot, unit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 442311 and sponsored by Whiteley Medical Supplies Pty Ltd, manufactured by Span Link International LLC in United States of America. The device registration started on February 26, 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 442311
Class I
Orthosis, leg, ankle/foot, unit
ARTG ID: 442311
Good Name: Whiteley Medical Supplies Pty Ltd - Orthosis, leg, ankle/foot, unit
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Intended Purpose

An orthosis that encompasses the ankle joint and the whole or part of the foot. The device is body worn & is intended to provide protection/support for injuries and conditions of the ankle and foot.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
442311
Start Date
February 26, 2024
Effective Date
February 26, 2024
Manufacturer
Country
United States of America
Address
28 West Jefryn Boulevard Suite C, Deer Park, New York, 11729