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Prosthesis, external, arm, component, hand, passive - ARTG 453513

Access comprehensive regulatory information for Prosthesis, external, arm, component, hand, passive in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 453513 and sponsored by Otto Bock Australia Pty Ltd, manufactured by Move Engineering BV in Netherlands. The device registration started on June 25, 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 453513
Class I
Prosthesis, external, arm, component, hand, passive
ARTG ID: 453513
Good Name: Otto Bock Australia Pty Ltd - Prosthesis, external, arm, component, hand, passive
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Intended Purpose

A range of prosthetic hand component which any alteration of shape is achieved by the direct application of external forces from the shoulder and/or elbow.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
453513
Start Date
June 25, 2024
Effective Date
June 25, 2024
Manufacturer
Country
Netherlands
Address
Nieuwe Kazernelaan 2 D 86, Ede, 6711JC