Australia TGA ARTG record

Keratoscope, line-powered

Australia TGA ARTG Registered Device · Carl Zeiss Pty Ltd · Carl Zeiss Meditec AG · Class IIa · Started May 17, 2023

Good Name: Carl Zeiss Pty Ltd - Keratoscope, line-powered

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: May 17, 2023
Effective Date: May 17, 2023

Sponsor

Name: Carl Zeiss Pty Ltd

Manufacturer

Name: Carl Zeiss Meditec AG
Country: Germany
Address: Goeschwitzer Strasse 51-52, Jena, D-07745

Intended purpose

Used to perform corneal topography and capture data to assist ophthalmic practitioners with the assessment of lacrimal dysfunctions. The device has been designed to capture and evaluate images of the anterior eye segment in the ophthalmic workflow.

About this record

Access comprehensive regulatory information for Keratoscope, line-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Carl Zeiss Pty Ltd, manufactured by Carl Zeiss Meditec AG in Germany. The device registration started on May 17, 2023.

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.