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Ultrasound system, imaging, application program software - ARTG 483045

Access comprehensive regulatory information for Ultrasound system, imaging, application program software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 483045 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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Class I
ARTG 483045
Class I
Ultrasound system, imaging, application program software
ARTG ID: 483045
Good Name: Gytech Pty Ltd - Ultrasound system, imaging, application program software
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Intended Purpose

AI powered follicular monitoring. used to identify, calculate and measure follicles of all sizes in a 2-second 2D or 3D cine loop of the ovary, conducted via a transvaginal ultrasound.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
483045
Start Date
March 19, 2025
Effective Date
March 19, 2025
Sponsor
Manufacturer
Country
Poland
Address
Swieradowska 47, Warsaw, 02-662