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Keratome blade, single-use - ARTG 297465

Access comprehensive regulatory information for Keratome blade, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 297465 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 IIa
ARTG 297465
Class IIa
Keratome blade, single-use
ARTG ID: 297465
Good Name: Aussie Medi Tech Pty Ltd - Keratome blade, single-use
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Intended Purpose

A surgical cutting device with a very sharp edge that is designed to be mounted into a keratome and is used to shave tissue from sections of the cornea. This is a single-use device.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
297465
Start Date
December 13, 2017
Effective Date
December 13, 2017
Manufacturer
Country
Germany
Address
Monbachstrasse 7/1, NEUHAUSEN, ENZKREIS, D-75242