Australia TGA ARTG record

BioBall™ Duo Head Bipolar - Femoral head bipolar component

Australia TGA ARTG Registered Device · Corin Australia Pty Ltd · Merete GmbH · Class III · Started December 22, 2015

Good Name: Corin Australia Pty Ltd - BioBall™ Duo Head Bipolar - Femoral head bipolar component

Device classification

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

Registration information

Start Date: December 22, 2015
Effective Date: December 22, 2015

Sponsor

Name: Corin Australia Pty Ltd

Manufacturer

Name: Merete GmbH
Country: Germany
Address: Alt-Lankwitz 102, Berlin, Germany, 12247

Intended purpose

The BioBall™ Duo Head Bipolar is part of the BioBall™ System which is designed for use in either primary or revision hip arthroplasty. It is intended to be used in the following indications: - Sliding pair revisions; and - Intra?operative correction of offset, neck length, lateralization and anteversion/retroversion with anchored prosthesis stem.

About this record

Access comprehensive regulatory information for BioBall™ Duo Head Bipolar - Femoral head bipolar component in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Corin Australia Pty Ltd, manufactured by Merete GmbH in Germany. The device registration started on December 22, 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.