Australia TGA ARTG record

Orthopaedic implantation application software

Australia TGA ARTG Registered Device · Emergo Asia Pacific Pty Ltd T/a Emergo Australia · MediCAD Hectec GmbH · Class Im · Started July 12, 2017

Good Name: Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Orthopaedic implantation application software

Device classification

Risk Class: Class Im
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: July 12, 2017
Effective Date: July 12, 2017

Sponsor

Name: Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Name: MediCAD Hectec GmbH
Country: Germany
Address: Opalstrasse 54, Altdorf, 84032

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.

About this record

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 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.