Light, surgical - ARTG 476167
Access comprehensive regulatory information for Light, surgical in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 476167 and sponsored by Draeger Australia Pty Ltd, manufactured by Dragerwerk AG & Co KGaA in Germany. The device registration started on January 20, 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.
Polaris surgical light system: The light system is classified as a surgical luminaire system in accordance with IEC 60601-2-41 and is intended to be used for the local illumination of the surgery and treatment area on the patient in operating, emergency and treatment rooms. Single surgical luminaire: A single light is classified as a single surgical luminaire according to IEC 60601-2-41. It is intended to be used for the local illumination of the surgery and treatment area for diagnostic and treatment purposes which can be interrupted without posing a hazard to the patient in the event the light fails. Camera MedView: The camera in the surgical light is provided to record the medical procedure. The recording can be used for the patient documentation, teaching and further education. The recordings cannot be used for diagnostic purposes.