Medi Soft SA

Medi Soft SA specializes in pulmonary function analysis systems for adult patients. These devices are primarily designed to measure lung volume and airflow metrics, such as those used in clinical settings to assess respiratory function. Examples include systems like the BodyBox and TransAir3.

Medi Soft SA is based in the United States. The company’s location is relevant for understanding its regulatory and operational context, particularly in relation to U.S. medical device compliance and reporting requirements.

Medi Soft SA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices in the U.S., allowing healthcare providers and regulators to verify device details, such as manufacturer information and classification.

Medi Soft SA’s pulmonary function analysis systems are classified as Class II devices. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.