LEVENTON SAU

Leventon SAU manufactures two primary types of medical devices: basic intravenous administration sets for noninvasive use and incentive spirometers. These devices are designed for controlled fluid delivery (e.g., DOSI-FLOW) and respiratory therapy (e.g., Rate Flow®), respectively. The company focuses on products that support patient care in fluid management and pulmonary rehabilitation.

Leventon SAU is based in the United States. While the company’s location influences its regulatory obligations (e.g., compliance with U.S. FDA requirements), it does not inherently determine whether its devices are authorised. Individual devices must undergo their own regulatory processes, such as FDA clearance or listing, to demonstrate safety and effectiveness for their intended use.

Leventon SAU’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it provides a standardized way to track and identify medical devices throughout their lifecycle, ensuring traceability for regulatory compliance, recalls, and post-market surveillance. Listing in the UDI database helps healthcare providers and authorities verify device authenticity and recall status.

Leventon SAU’s devices fall under Class II classification in the U.S. regulatory framework. This classification indicates that the devices pose moderate risk and require special controls beyond general controls (e.g., performance standards, post-market surveillance) to ensure their safety and effectiveness. While Class II devices do not require pre-market approval like Class III devices, they still undergo rigorous evaluation to meet regulatory requirements before being authorised for use.