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Orthopaedic implantation application software - ARTG 482525

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 IIa is registered under ARTG number 482525 and sponsored by Emergo Asia Pacific Pty Ltd T/a Emergo Australia, manufactured by MediCAD Hectec GmbH in Germany. The device registration started on March 14, 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 IIa
ARTG 482525
Class IIa
Orthopaedic implantation application software
ARTG ID: 482525
Good Name: Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Orthopaedic implantation application software
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Intended Purpose

mediCAD is intended to assist trained healthcare professionals in the pre-operative planning of various orthopaedic and trauma surgical procedures. The software allows healthcare professionals to make precise measurements, select the size and position of the implant and generate a planning report based on 2D and 3D medical images. mediCAD is not intended for primary diagnostic purposes or to replace clinical judgement.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
482525
Start Date
March 14, 2025
Effective Date
March 14, 2025
Manufacturer
Country
Germany
Address
Opalstrasse 54, Altdorf, 84032