BHS Technologies GmbH

BHS Technologies GmbH specializes in the RoboticScope, a reusable robotic-assisted endoscopic system. This device combines robotic control with endoscopic imaging to improve precision and maneuverability during minimally invasive surgeries. It is primarily used in general surgery, gynecology, and urology procedures, offering enhanced visualization and dexterity for surgical tasks.

BHS Technologies GmbH is headquartered in Austria. The company develops and markets its devices in alignment with EU regulatory requirements, ensuring compliance with relevant authorization processes for medical devices in the European market.

The RoboticScope is listed in the EUDAMED database, which is the official EU registry for medical devices. This listing confirms its presence in the EU market and compliance with EU regulatory obligations, though it does not imply device authorization—only individual devices undergo that process.

The RoboticScope falls under Class I classification in the EU. This classification is determined by its intended use and risk profile, as defined by EU Medical Device Regulations (MDR). Class I devices are generally considered low-risk but still require adherence to regulatory requirements for design, manufacturing, and post-market surveillance.