Australia TGA ARTG record

Specimen receptacle IVDs

Australia TGA ARTG Registered Device · Kirby Institute - COVID-19 Remote Response · Huachenyang (Shenzhen) Technology Co Ltd · Class I · Started April 20, 2020

Good Name: Kirby Institute - COVID-19 Remote Response - Specimen receptacle IVDs

Device classification

Risk Class: Class I
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: April 20, 2020
Effective Date: April 20, 2020

Sponsor

Name: Kirby Institute - COVID-19 Remote Response

Manufacturer

Name: Huachenyang (Shenzhen) Technology Co Ltd
Country: China
Address: Area A F8/Bldg 4 Hengchangrong High Tech Park, Shajing Baoan, Shenzhen Guangdong, 518104

Intended purpose

This kit consists of a nasopharyngeal swab and a 10 mL tube containing 3 mL of universal transport medium suitable for virus, chlamydia, gonorrhoea, mycoplasma and ureaplasma samples.

About this record

Access comprehensive regulatory information for Specimen receptacle IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Kirby Institute - COVID-19 Remote Response, manufactured by Huachenyang (Shenzhen) Technology Co Ltd in China. The device registration started on April 20, 2020.

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.