Australia flagARTG 473711

Multiple-bacteria IVDs

ARTG ID: 473711 · Pure Sponsor Pty Ltd · Guangzhou Hybribio Medicine Technology Ltd · Class IIb · Started December 18, 2024

Good Name: Pure Sponsor Pty Ltd - Multiple-bacteria IVDs

Device classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration information
ARTG ID
473711
Start Date
December 18, 2024
Effective Date
December 18, 2024
Sponsor
Manufacturer
Country
China
Address
No 71 Fenghuang 3rd Road Sino-Singapore Knowledge City, Nine Dragon Town Huangpu District Guangzhou, Guangdong, 510000
Intended purpose

Hybribio STD3 Real-time PCR Kit is designed for in-vitro qualitative detection of 3 sexually transmitted pathogens: Chlamydia trachomatis, Neisseria gonorrhoeae, and Ureaplasma urealyticum in male urethral secretions and female cervical exfoliated cells. It is used as an aid in diagnosis of Chlamydia, Gonorrhea and Ureaplasma in symptomatic (e.g. gonorrhoea and non-gonococcal urethritis, cervicitis, etc) individuals

About this record

Access comprehensive regulatory information for Multiple-bacteria IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 473711 and sponsored by Pure Sponsor Pty Ltd, manufactured by Guangzhou Hybribio Medicine Technology Ltd in China. The device registration started on December 18, 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.

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