Surgical instrument washer/disinfector (chemical/thermal) - ARTG 484126
Access comprehensive regulatory information for Surgical instrument washer/disinfector (chemical/thermal) in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 484126 and sponsored by Henry Schein Halas, manufactured by MELAG Medizintechnik GmbH & Co KG in Germany. The device registration started on March 26, 2025.
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.
Intended for use in a medical context such as a clinic or medical and dental practices as a washer-disinfector intended for reprocessing medical instruments prior to their re-use or a further reprocessing step such as sterilization in a steam sterilizer. Thermostable medical instruments (i.e. instruments which are heat resistant to a temperature of 95 °C) and invasive thermostable instruments can be subjected to automatic reprocessing as long as they are suitable for this purpose and have been approved for such treatment by their manufacturer. The cleaning is performed using water in combination with a process agent. Subsequent disinfection is thermal disinfection. This device is not intended to be used in a patient environment.