Australia TGA ARTG record

Bone-resection orthopaedic reamer, single-use

Australia TGA ARTG Registered Device · Medacta Australia Pty Ltd · Medacta International SA · Class IIa · Started May 20, 2024

Good Name: Medacta Australia Pty Ltd - Bone-resection orthopaedic reamer, single-use

Device classification

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

Registration information

Start Date: May 20, 2024
Effective Date: May 20, 2024

Sponsor

Name: Medacta Australia Pty Ltd

Manufacturer

Name: Medacta International SA
Country: Switzerland
Address: Strada Regina, Castel San Pietro, CH-6874

Intended purpose

Single use instruments intended to be used as sterile surgical instruments to assist intraoperatively in a surgical procedure. The single use instruments are supplied sterile and are intended for single use only.

About this record

Access comprehensive regulatory information for Bone-resection orthopaedic reamer, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Medacta Australia Pty Ltd, manufactured by Medacta International SA in Switzerland. The device registration started on May 20, 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.