FUJIFILM medwork GmbH

FUJIFILM medwork GmbH specializes in single-use valves for endoscopic procedures. Their devices include air/water valves, suction valves, working-channel valves, and in-line backflow valves. These components are designed to be used within endoscope systems to regulate fluid flow and minimize contamination risks during medical examinations.

FUJIFILM medwork GmbH operates from the United States. The company’s location is relevant for understanding regulatory oversight and compliance, as it aligns with FDA jurisdiction for device classification and listing.

FUJIFILM medwork GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps healthcare providers and regulators identify and track specific medical devices, ensuring traceability and compliance with regulatory requirements.

FUJIFILM medwork GmbH’s valves are classified as Class II devices by the FDA. This classification is based on the level of risk associated with the device’s intended use, where Class II devices require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.