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Multiple-bacteria IVDs - ARTG 367250

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 367250 and 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.

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TGA ARTG Official Data
Class IIb
ARTG 367250
Class IIb
Multiple-bacteria IVDs
ARTG ID: 367250
Good Name: R-Biopharm Pty Ltd - Multiple-bacteria IVDs
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Intended Purpose

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

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
367250
Start Date
May 26, 2021
Effective Date
May 26, 2021
Manufacturer
Country
Denmark
Address
Herredsvejen 2, Hillerod, 3400