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Affinis Inverse metaglene CP - Reverse shoulder prosthesis - ARTG 377932

Access comprehensive regulatory information for Affinis Inverse metaglene CP - Reverse shoulder prosthesis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 377932 and sponsored by Mathys Orthopaedics Pty Ltd, manufactured by Mathys Ltd Bettlach in Switzerland. The device registration started on November 15, 2021.

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 377932
Class III
Affinis Inverse metaglene CP - Reverse shoulder prosthesis
ARTG ID: 377932
Good Name: Mathys Orthopaedics Pty Ltd - Affinis Inverse metaglene CP - Reverse shoulder prosthesis
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Intended Purpose

Device intended to restore the function of the shoulder and/or to relieve pain in skeletally mature patients. Indications include: โ€ข Grossly deficient rotator cuff with arthropathy or irreparable functional deformity โ€ข Revision of failed shoulder prosthesis or fracture treatment (conservative or surgical) with an irreparable rotator cuff โ€ข Tumour-related structural defects of the proximal humerus

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
377932
Start Date
November 15, 2021
Effective Date
November 15, 2021
Manufacturer
Country
Switzerland
Address
Robert Mathys Strasse 5 Bettlach, 2544