MEDISOFT RAM ITALIA SRL

Medisoft Ram Italia Srl specializes in cardiopulmonary stress exercise treadmills, which are used for graded exercise testing. These devices evaluate a patient’s physiological responses—such as heart rate, oxygen consumption, and ventilation—during controlled physical exertion. The data helps assess cardiovascular fitness and diagnose conditions like coronary artery disease.

The company is based in the United States. While the name includes ‘Italia,’ the operational headquarters and manufacturing are located within the US market.

Medisoft Ram Italia Srl’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry tracks Class I medical devices authorized for commercial distribution in the US, ensuring traceability and compliance with regulatory requirements.

Medisoft Ram Italia Srl’s cardiopulmonary stress exercise treadmills are classified as Class I medical devices by the FDA. This classification applies to devices posing minimal risk to patients, typically those with simple, non-invasive functions. Class I devices still require compliance with FDA’s general controls but may not need pre-market approval.