Bentley InnoMed GmbH

Bentley InnoMed GmbH specializes in peripheral vascular intervention infusion catheters. These devices, such as the BeBack Crossing Catheter, are specifically designed for use in vascular procedures to deliver fluids or medications directly into peripheral blood vessels. The focus is on supporting interventional treatments by ensuring precise and controlled infusion during medical interventions.

Bentley InnoMed GmbH is based in the United States. The company operates within the regulatory framework of the U.S., which governs the development, manufacturing, and distribution of its medical devices to ensure compliance with applicable standards and requirements.

Bentley InnoMed GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices in the United States, ensuring transparency and traceability for regulatory and market surveillance purposes.

Bentley InnoMed GmbH’s devices, such as the BeBack Crossing Catheter, are classified as FDA Class II medical devices. This classification indicates that while these devices pose moderate risk, they still require compliance with specific regulatory controls to ensure safety and effectiveness, including premarket notifications and adherence to manufacturing standards.