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PEEK Skull Repairing System - Cranioplasty plate, non-alterable - ARTG 471106

Access comprehensive regulatory information for PEEK Skull Repairing System - Cranioplasty plate, non-alterable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 471106 and sponsored by Innovative Medcare Technology Pty Ltd, manufactured by Kontour (Xi'an) Medical Technology Co. Ltd. in China. The device registration started on November 29, 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 IIb
ARTG 471106
Class IIb
PEEK Skull Repairing System - Cranioplasty plate, non-alterable
ARTG ID: 471106
Good Name: Innovative Medcare Technology Pty Ltd - PEEK Skull Repairing System - Cranioplasty plate, non-alterable
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Intended Purpose

The PEEK Skull Repairing Systems are applicable to the surgical treatment for repairing and reconstruction of the skull defect. It consists of PEEK Bone plates. Tools for Implantation may be included. These patient matched medical devices are for long term use and are not in direct contact with the CNS or CCS.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
471106
Start Date
November 29, 2024
Effective Date
November 29, 2024
Manufacturer
Country
China
Address
No 1451 1st Biyuan Road High-Tech District, Xi'an, Shaanxi, 710065