ARTG 462390

General laboratoryware IVDs

ARTG ID: 462390 · Gytech Pty Ltd · Halotech DNA SL · Class I · Started September 19, 2024

Good Name: Gytech Pty Ltd - General laboratoryware IVDs

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

Name: Gytech Pty Ltd

Manufacturer

Name: Halotech DNA SL
Country: Spain
Address: Calle faraday 7, Madrid, 28049

Intended purpose

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

About this record

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.