DuPhaMed B.V.

DuPhaMed B.V. specializes in two primary categories of medical devices: reusable dental x-ray film holders and single-use medical equipment/instrument drapes. The dental x-ray film holders, such as the Cefla and Care Stream Dental series, are designed to stabilize film during dental imaging, while the DenBite line also falls under reusable dental film holders. These products are tailored for use in dental and medical environments to enhance imaging quality and procedural hygiene.

DuPhaMed B.V. is based in the United States. Its devices are intended for commercial distribution in the U.S., where they must comply with applicable regulatory standards for medical devices. The company’s focus on these markets ensures its products meet the necessary requirements for use in dental and medical settings within the country.

DuPhaMed B.V.’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry is part of the U.S. regulatory framework for tracking and identifying medical devices, ensuring transparency and traceability for Class I devices like those manufactured by the company.

DuPhaMed B.V.’s devices are classified as Class I medical devices under FDA regulations. This classification is typically assigned to low-risk devices that pose minimal potential harm to users. Class I devices often require general controls, such as good manufacturing practices, to ensure safety and effectiveness, without needing additional premarket approval.