FDA Registration Medical Devices
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- Hi annatrade,
Gowns, gloves, face shields, goggles, facemasks and respirators are Medical Devices. Therefore, an FDA User Fee of $5,672.00 is required for the annual Establishment Registration (Fiscal Year 2022).
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.itbhdg.com/medical-devices-registration/
https://www.itbhdg.com/fda-fees/
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.itbhdg.com/medical-devices-registration/
https://www.itbhdg.com/fda-fees/
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