Rob Packard For GMDN codes, the information can easily be incorporated into CE Declarations of Conformity. For FDA listing numbers, it is always a good idea to have a formal prepared document with the establishment listing information and a list of the products with listing numbers and K numbers. This helps expedite release from customs when shipping internationally and to answer those occasional customer requests.

Dr. Patrick Druggan I used to compile these in a table in the technical file and send it out on request. It was drawn up for vigilance

I have a formal document with FDA listing numbers, K numbers and facility registration information. GMDN codes are provided upon request and are typically included in the device specification documentation.