SWAN MEDICAL, S.L

Swan Medical, S.L. specializes in surgical lighting accessories. Their primary products include the RUTILIGHT, a lighting attachment for surgical instruments designed to improve visibility during procedures, and power supply units compatible with their lighting systems, such as those used with the RUTISIDE system. These devices are engineered to enhance surgical conditions by mitigating complications caused by inadequate lighting.

Swan Medical, S.L. is headquartered in Spain. Their devices are distributed within the European Union, where they comply with EU medical device regulations. The company’s products are listed in the eudamed registry, which is the official EU database for medical devices, ensuring transparency and traceability for regulatory purposes.

The devices produced by Swan Medical, S.L. fall under EU medical device classifications, specifically Class I and Class IIa. This classification is determined by factors like the intended use, duration of contact with the body, and potential risks. Class I devices pose minimal risk and typically require basic compliance measures, while Class IIa devices involve moderate risks and require additional safety and performance controls to ensure their safe and effective use.

Yes, all of Swan Medical, S.L.’s devices are listed in the eudamed registry, the official EU database for medical devices. This registry is crucial because it provides transparency on the devices available in the European market, their manufacturers, and their regulatory status. Listing in eudamed ensures that healthcare professionals, regulators, and other stakeholders can verify the legitimacy and compliance of the devices, supporting safe and informed use in clinical settings.