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BIOLOXยฎ Delta Ceramic Femoral Heads (D Heads) - Ceramic femoral head prosthesis - ARTG 458111

Access comprehensive regulatory information for BIOLOXยฎ Delta Ceramic Femoral Heads (D Heads) - Ceramic femoral head prosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 458111 and sponsored by Compliance Management Solutions, manufactured by Serf in France. The device registration started on August 01, 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.

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Class III
ARTG 458111
Class III
BIOLOXยฎ Delta Ceramic Femoral Heads (D Heads) - Ceramic femoral head prosthesis
ARTG ID: 458111
Good Name: Compliance Management Solutions - BIOLOXยฎ Delta Ceramic Femoral Heads (D Heads) - Ceramic femoral head prosthesis
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Intended Purpose

Biolox Delta Ceramic Femoral Heads (D Heads) are intended to be used in the following medical conditions: Osteoarthritis (primary and secondary),Femoral neck fracture, Necrosis of the femoral head, Dysplasia, Revision in case of breakage of a ceramic component when used with a ceramic liner.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
458111
Start Date
August 01, 2024
Effective Date
August 01, 2024
Manufacturer
Name
Serf
Country
France
Address
85 Avenue des Bruyeres, 69150 Decines-Charpieu