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Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs

Access comprehensive regulatory information for Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) 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 R-Biopharm AG in Germany. The device registration started on September 17, 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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TGA ARTG Official Data
Class IIb
Class IIb
Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs
Australia TGA ARTG Registered Device
Good Name: R-Biopharm Pty Ltd - Herpes simplex virus (HSV) (Human herpesvirus 1 & 2) IVDs
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Intended Purpose

Intended to provide information about infection with or exposure to Herpes simplex virus 1 and/or Herpes simplex virus 2

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
September 17, 2015
Effective Date
September 17, 2015
Manufacturer
Country
Germany
Address
An der neuen Bergstrasse 17, Darmstadt, 64297