ARTG 372710

Legionella IVDs

ARTG ID: 372710 · R-Biopharm Pty Ltd · SSI Diagnostica A/S · Class IIb · Started August 12, 2021

Good Name: R-Biopharm Pty Ltd - Legionella IVDs

Device classification

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

Registration information

ARTG ID: 372710
Start Date: August 12, 2021
Effective Date: August 12, 2021

Sponsor

Name: R-Biopharm Pty Ltd

Manufacturer

Name: SSI Diagnostica A/S
Country: Denmark
Address: Herredsvejen 2, Hillerod, 3400

Intended purpose

To be used in testing to provide information about infection with or exposure to legionella bacteria

About this record

Access comprehensive regulatory information for Legionella IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 372710 and sponsored by R-Biopharm Pty Ltd, manufactured by SSI Diagnostica A/S in Denmark. The device registration started on August 12, 2021.

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.