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Embryo-assessment microscope camera system application software - ARTG 483070

Access comprehensive regulatory information for Embryo-assessment microscope camera system application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 483070 and sponsored by Gytech Pty Ltd, manufactured by MIM Fertility Sp zo o in Poland. The device registration started on March 19, 2025.

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 I
ARTG 483070
Class I
Embryo-assessment microscope camera system application software
ARTG ID: 483070
Good Name: Gytech Pty Ltd - Embryo-assessment microscope camera system application software
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Intended Purpose

Embryoaid is a software application Based on AI, designed to support embryologists in the process of embryo assessment during IVF treatment. By examining the user uploaded data ( images or videos ), the application presents a classification corresponding to the developmental potential of embryos prior to the transfer procedure.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
483070
Start Date
March 19, 2025
Effective Date
March 19, 2025
Sponsor
Manufacturer
Country
Poland
Address
Swieradowska 47, Warsaw, 02-662