Australia TGA ARTG record

Multiple-bacteria IVDs

Australia TGA ARTG Registered Device · R-Biopharm Pty Ltd · SSI Diagnostica A/S · Class IIb · Started May 26, 2021

Good Name: R-Biopharm Pty Ltd - Multiple-bacteria IVDs

Device classification

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

Registration information

Start Date: May 26, 2021
Effective Date: May 26, 2021

Sponsor

Name: R-Biopharm Pty Ltd

Manufacturer

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

Intended purpose

IVDs that are intended to be used in testing to provide information about infection with or exposure multiple specified bacterial organisms

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 sponsored by R-Biopharm Pty Ltd, manufactured by SSI Diagnostica A/S in Denmark. The device registration started on May 26, 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.