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Severe acute respiratory syndrome-associated coronavirus IVDs

Australia TGA ARTG Registered Device · VITRYL AUS PTY LTD · Labnovation Technologies Inc · Class IIb · Started May 05, 2022

Good Name: VITRYL AUS PTY LTD - Severe acute respiratory syndrome-associated coronavirus IVDs

Device classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration information
Start Date
May 05, 2022
Effective Date
December 05, 2022
Sponsor
Manufacturer
Country
China
Address
101 and 5th Floor Building 1 No 68 18th Road Guangming Hi-tech Park, Tangjia Community Fenghuang Street Guangming District, Shenzhen, Guangdong, 518107
Intended purpose

Intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 from symptomatic individuals for self-testing by lay persons (nasal swab).

About this record

Access comprehensive regulatory information for Severe acute respiratory syndrome-associated coronavirus IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by VITRYL AUS PTY LTD, manufactured by Labnovation Technologies Inc in China. The device registration started on May 05, 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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