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Multiple-viruses IVDs - ARTG 401010

Access comprehensive regulatory information for Multiple-viruses IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 401010 and sponsored by Touch Biotechnology Pty Ltd, manufactured by Vitrosens Biyoteknoloji LTD STI in Turkey. The device registration started on December 13, 2022.

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 IIb
ARTG 401010
Class IIb
Multiple-viruses IVDs
ARTG ID: 401010
Good Name: Touch Biotechnology Pty Ltd - Multiple-viruses IVDs
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Intended Purpose

Intended to detect Influenza A/B and the novel coronavirus SARS-CoV-2 from symptomatic individuals at the point of care by trained health professionals (Nasopharyngeal)

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
401010
Start Date
December 13, 2022
Effective Date
September 11, 2024
Manufacturer
Country
Turkey
Address
Serifali Mah Sht Sk No 17/1, Umraniye, Istanbul