Pure Global

Information system software, application program, patient record - ARTG 405005

Access comprehensive regulatory information for Information system software, application program, patient record in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 405005 and sponsored by Carl Zeiss Pty Ltd, manufactured by Carl Zeiss Meditec AG in Germany. The device registration started on February 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.

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TGA ARTG Official Data
Class IIb
ARTG 405005
Class IIb
Information system software, application program, patient record
ARTG ID: 405005
Good Name: Carl Zeiss Pty Ltd - Information system software, application program, patient record
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Intended Purpose

A calculation tool intended to assist the ophthalmic healthcare professional with data collection and analysis of their laser vision correction outcomes with refractive lasers. The tool will then propose nomograms as an output, based on the data selected. The proposed nomogram can be used as an input for refractive lasers.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
405005
Start Date
February 17, 2023
Effective Date
February 17, 2023
Manufacturer
Country
Germany
Address
Goeschwitzer Strasse 51-52, Jena, D-07745