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Hydraulic/pneumatic external knee prosthesis - ARTG 476185

Access comprehensive regulatory information for Hydraulic/pneumatic 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 476185 and sponsored by Otto Bock Australia Pty Ltd, manufactured by Move Engineering BV in Netherlands. The device registration started on January 20, 2025.

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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Class I
ARTG 476185
Class I
Hydraulic/pneumatic external knee prosthesis
ARTG ID: 476185
Good Name: Otto Bock Australia Pty Ltd - Hydraulic/pneumatic external knee prosthesis
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Intended Purpose

A range of children's lower limb hydraulic and/or pneumatic prostheses designed to functionally replace, impart or total, an absent knee. The knee is designed for two body weights namely 25kg and 45 kg.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
476185
Start Date
January 20, 2025
Effective Date
January 20, 2025
Manufacturer
Country
Netherlands
Address
Nieuwe Kazernelaan 2 D 86, Ede, 6711JC