05/01/2023 Other Services
If a manufacturer's medical device falls into a generic category of exempted class I devices, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, these manufacturers are required to register their establishment and list their products.
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.fda.itbhdg.com/product/medical-devices/
A DUNS Number is now required for all U.S. FDA Registrations: Food Facility, Food Canning Establishment, Cosmetic Establishment, Drug Establishment, M...
If the specified FCE (Food Canning Establishment) number or SID (Submission Identifier) is not on file, it may indicate that the establishment has not...
If the specified FCE (Food Canning Establishment) number or SID (Submission Identifier) is not on file, it may indicate that the establishment has not...
Sunglasses, spectacle frames, spectacle lens, and magnifying spectacles are medical devices exempt from the Premarket Notification 510(k) submission t...
More Details