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Clinical data collection/management information application software - ARTG 409491

Access comprehensive regulatory information for Clinical data collection/management information application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 409491 and sponsored by iCare World Australia Pty Ltd, manufactured by Icare Finland Oy in Finland. The device registration started on May 24, 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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Class IIa
ARTG 409491
Class IIa
Clinical data collection/management information application software
ARTG ID: 409491
Good Name: iCare World Australia Pty Ltd - Clinical data collection/management information application software
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Intended Purpose

iCare CLINIC is a software intended for storing and viewing of ophthalmic measurement data and for transferring it to external systems, supporting clinical decision making. iCare PATIENT2 is a mobile app intended for transferring ophthalmic measurement data to iCare CLINIC or to an external system. It also has the capability of displaying ophthalmic measurement data and aiding in glaucoma management. iCare EXPORT is a software application intended for transferring ophthalmic measurement data to iCare CLINIC or to an external system. It also has the capability of displaying ophthalmic measurement data. iCare CLINIC, PATIENT2 and EXPORT are all indicated for use by healthcare professionals and lay-persons.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
409491
Start Date
May 24, 2023
Effective Date
May 24, 2023
Manufacturer
Country
Finland
Address
Ayritie 22, Vantaa, 01510