Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a medical device imported into the United States must identify a United States agent (U.S. Agent) for that establishment.

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T: +1 855 389 7344
T: +1 855 510 2240
T: +44 800 610 1577

https://www.usfda.info/fda-us-agent/