Netherlands FDA 510(k) Overview
Leading Netherlands FDA 510(k) manufacturers include Philips Medical Systems Nederland B.V., Cavex Holland BV, Pie Medical Imaging BV and 139 others.
Dutch medical device manufacturers have submitted 518 FDA 510(k) notifications since 1993, with a 99.2% clearance rate across 142 manufacturers. The Netherlands medtech sector is active in imaging systems, radiation therapy devices, clinical diagnostics and software-based medical devices, supported by a well-developed regulatory affairs ecosystem.
Active in FDA 510(k) submissions since 1993. Many Netherlands manufacturers work with FDA regulatory consultants to support U.S. market entry.