General Medical Italia LTD Swiss Branch

General Medical Italia specializes in orthopedic and trauma fixation devices. These include systems like the Lucerna U-ARM, a modular external fixation system used for stabilizing fractures externally, and the Genève 40 M, a locking compression plate designed for internal fixation of long bone fractures. The company also produces the Lucerna RF-TILT, a radiofrequency-assisted external fixator that allows gradual adjustments to bone alignment.

General Medical Italia operates from its Swiss branch in Switzerland. While the company is based in Switzerland, its devices are classified under the EU Medical Device Regulation (MDR) as Class IIb, meaning they must undergo conformity assessment by a Notified Body to comply with EU requirements. The Swiss branch likely facilitates regulatory processes, but individual devices must meet EU standards for market placement within the European Union.

Yes, General Medical Italia’s devices are registered in EUDAMED, the official European Union database for medical devices. This registry is mandatory for manufacturers to declare their devices, including key details like device identification, classification, and regulatory status. Since these devices fall under Class IIb, they require traceability and transparency in the EU market, which EUDAMED ensures.

General Medical Italia’s devices are classified as Class IIb under the EU Medical Device Regulation (MDR). This classification indicates a higher risk level, requiring rigorous conformity assessment by a Notified Body to ensure safety and performance before market placement. Class IIb devices must undergo clinical evaluations, technical documentation reviews, and manufacturing quality checks to meet MDR standards.