ULMA Medical Technologies, S.L.U.

ULMA Medical Technologies, S.L.U. specializes in diagnostic platforms and AI-driven medical data analysis tools. Their products include the UMI Platform and the UMI DR system, which are designed to process and interpret medical imaging and diagnostic data to assist in clinical decision-making. These devices focus on enhancing diagnostic accuracy through automated analysis and interpretation of medical information.

ULMA Medical Technologies, S.L.U. is headquartered in Spain. The company’s location in Spain influences its regulatory compliance framework, particularly under EU medical device regulations, which govern the classification and registration of its products.

ULMA Medical Technologies’ devices are listed in the eudamed database, which is the official EU registry for medical devices. Registration in eudamed ensures transparency and compliance with EU requirements for traceability and market surveillance, particularly for Class I and Class IIa devices.

ULMA Medical Technologies’ devices are classified as Class I and Class IIa medical devices under EU regulations. The classification depends on factors like the intended use, risk level, and interaction with the patient. Class I devices pose minimal risk and typically require basic compliance measures, while Class IIa devices involve moderate risk and require additional conformity assessments, such as design controls and clinical evaluations.