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Keratome, line-powered - ARTG 297464

Access comprehensive regulatory information for Keratome, line-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 297464 and sponsored by Aussie Medi Tech Pty Ltd, manufactured by Gebauer Medizintechnik GmbH in Germany. The device registration started on December 13, 2017.

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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TGA ARTG Official Data
Class IIb
ARTG 297464
Class IIb
Keratome, line-powered
ARTG ID: 297464
Good Name: Aussie Medi Tech Pty Ltd - Keratome, line-powered
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Intended Purpose

An electrically powered device consisting of a Console and an Artificial Anterior Chamber intended to create a thin lamella with living endothelial cells from a donor cornea. The lamella created can be used for a lamellar (partial thickness) transplant.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
297464
Start Date
December 13, 2017
Effective Date
December 13, 2017
Manufacturer
Country
Germany
Address
Monbachstrasse 7/1, NEUHAUSEN, ENZKREIS, D-75242