FDA 510(k) Medical Device Manufacturers - Netherlands

Leading Netherlands FDA 510(k) manufacturers include Philips Medical Systems Nederland B.V., Light Tree Ventures Europe B.V., Kuros Biosciences B.V and 55 others.

Dutch medical device manufacturers have submitted 174 FDA 510(k) notifications since 2017, with a 98.9% clearance rate across 57 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 2017. Many Netherlands manufacturers work with FDA regulatory consultants to support U.S. market entry.