Baxter Healthcare SA

Baxter Healthcare SA specializes in infusion pumps under the brand FOLFUSOR. These devices are designed for the controlled administration of intravenous fluids and chemotherapy agents in clinical environments, such as hospitals and ambulatory care settings. They are engineered to provide programmable infusion rates and safety features to ensure precise dosing and reduce treatment risks.

Baxter Healthcare SA is headquartered in Switzerland. As a Swiss manufacturer, the company must comply with both Swiss medical device regulations and EU requirements if its devices are marketed within the European Union. The FOLFUSOR infusion pumps are listed in the EUDAMED database, demonstrating adherence to EU Medical Device Regulations (MDR) or prior directives, depending on the device classification and market entry date.

Baxter Healthcare SA’s FOLFUSOR infusion pumps are listed in the EUDAMED database, which is the official EU registry for medical devices. This listing is required under EU Medical Device Regulations (MDR) or the former Medical Device Directives (MDD) to ensure transparency, traceability, and compliance with regulatory requirements for devices marketed in the European Union.

The FOLFUSOR infusion pumps are classified under Class I, Class IIa, and Class IIb in the EU regulatory framework. This classification reflects the varying levels of risk associated with the devices: Class I devices pose the lowest risk, while Class IIb devices involve higher risks requiring more stringent design controls and clinical evaluations. The classification determines the regulatory scrutiny and documentation requirements each device must meet before market placement.