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Orthosis, arm, shoulder/elbow, unit - ARTG 254092

Access comprehensive regulatory information for Orthosis, arm, shoulder/elbow, unit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 254092 and sponsored by Orthotic & Prosthetic Centre Pty Ltd, manufactured by Oped GmbH in Germany. The device registration started on August 11, 2015.

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 254092
Class I
Orthosis, arm, shoulder/elbow, unit
ARTG ID: 254092
Good Name: Orthotic & Prosthetic Centre Pty Ltd - Orthosis, arm, shoulder/elbow, unit
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Intended Purpose

Non measuring immobilization and exercise equipment, offering to increase ROM of the shoulder. Used as postoperative treatment, the device is typically used after shoulder surgery like rotator cuff repair or shoulder dislocation

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
254092
Start Date
August 11, 2015
Effective Date
August 11, 2015
Manufacturer
Country
Germany
Address
Medizinpark 1 Valley, Oberlaindern, 83626