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BioBall™ Duo Head Bipolar - Femoral head bipolar component - ARTG 266540

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 registered under ARTG number 266540 and 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.

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Class III
ARTG 266540
Class III
BioBall™ Duo Head Bipolar - Femoral head bipolar component
ARTG ID: 266540
Good Name: Corin Australia Pty Ltd - BioBall™ Duo Head Bipolar - Femoral head bipolar component
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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.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
266540
Start Date
December 22, 2015
Effective Date
December 22, 2015
Manufacturer
Country
Germany
Address
Alt-Lankwitz 102, Berlin, Germany, 12247