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Orthopaedic implantation application software - ARTG 291391

Access comprehensive regulatory information for Orthopaedic implantation application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Im is registered under ARTG number 291391 and sponsored by Emergo Asia Pacific Pty Ltd T/a Emergo Australia, manufactured by MediCAD Hectec GmbH in Germany. The device registration started on July 12, 2017.

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 Im
ARTG 291391
Class Im
Orthopaedic implantation application software
ARTG ID: 291391
Good Name: Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Orthopaedic implantation application software
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Intended Purpose

The software is intended for the pre-operative planning of implants in joint replacement surgery and the care of injuries in orthopedic surgery and trauma surgery. Thereby the software enables the user to plan, apply and track/trace the planning required by the legislator.

Device Classification
Risk Class
Class Im
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
291391
Start Date
July 12, 2017
Effective Date
July 12, 2017
Manufacturer
Country
Germany
Address
Opalstrasse 54, Altdorf, 84032