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General laboratoryware IVDs - ARTG 462390

Access comprehensive regulatory information for General laboratoryware IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 462390 and sponsored by Gytech Pty Ltd, manufactured by Halotech DNA SL in Spain. The device registration started on September 19, 2024.

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 462390
Class I
General laboratoryware IVDs
ARTG ID: 462390
Good Name: Gytech Pty Ltd - General laboratoryware IVDs
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Intended Purpose

Used to determine the DNA fragmentation rate of cumulus oophoius cells, as an indicator of oocyte quality.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
462390
Start Date
September 19, 2024
Effective Date
September 19, 2024
Sponsor
Manufacturer
Country
Spain
Address
Calle faraday 7, Madrid, 28049