Australia flagARTG 261301

Clinical chemistry therapeutic drug monitoring IVDs

ARTG ID: 261301 · R-Biopharm Pty Ltd · R-Biopharm AG · Class IIa · Started October 16, 2015

Good Name: R-Biopharm Pty Ltd - Clinical chemistry therapeutic drug monitoring IVDs

Device classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration information
ARTG ID
261301
Start Date
October 16, 2015
Effective Date
October 16, 2015
Sponsor
Manufacturer
Country
Germany
Address
An der neuen Bergstrasse 17, Darmstadt, 64297
Intended purpose

Intended to be used in monitoring of therapeutic drug levels in a clinical specimen

About this record

Access comprehensive regulatory information for Clinical chemistry therapeutic drug monitoring IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 261301 and sponsored by R-Biopharm Pty Ltd, manufactured by R-Biopharm AG in Germany. The device registration started on October 16, 2015.

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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