Pure Global

Mechanical-resistance external ankle-foot prosthesis - ARTG 461986

Access comprehensive regulatory information for Mechanical-resistance external ankle-foot prosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 461986 and sponsored by Ossur Australia Pty Ltd, manufactured by College Park Industries Inc in United States of America. The device registration started on September 05, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
ARTG 461986
Class I
Mechanical-resistance external ankle-foot prosthesis
ARTG ID: 461986
Good Name: Ossur Australia Pty Ltd - Mechanical-resistance external ankle-foot prosthesis
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

External lower limb devices are designed to replace one or more functions of the biologic human (adult and children) foot or ankle-foot system.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
461986
Start Date
September 05, 2024
Effective Date
September 05, 2024
Manufacturer
Country
United States of America
Address
27955 College Park Drive, Warren, MI, 48088-4877