Medical Device Listing


This service requires filling out Form K – Medical Device Listing



Medical U.S. Agent and Establishment Registration Support

Medical Establishments are also required to list the devices and the activities that are performed on those devices. Included in our medical device listing fee is:

  • Assistance in determining your device’s likely classification
  • Preparation and submittal of your device listings to FDA
  • Process updates and cancellations as needed
  • Our Certificate of Registration verifying you have a valid FDA Registration