Australia flagARTG 399643

Severe acute respiratory syndrome-associated coronavirus IVDs

ARTG ID: 399643 · Nationwide Asset Management Consolidated Pty Ltd · Hangzhou Testsea Biotechnology Co Ltd · Class IIb · Started November 18, 2022

Good Name: Nationwide Asset Management Consolidated Pty Ltd- Severe acute respiratory syndrome-associated coronavirus IVDs

Device classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration information
ARTG ID
399643
Start Date
November 18, 2022
Effective Date
September 11, 2024
Sponsor
Manufacturer
Country
China
Address
3rd Floor Building 6 North No 8-2 Keji Avenue Yuhang District, Hangzhou, Zhejiang Province, 311121
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 registered under ARTG number 399643 and sponsored by Nationwide Asset Management Consolidated Pty Ltd, manufactured by Hangzhou Testsea Biotechnology Co Ltd in China. The device registration started on November 18, 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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