Product Categories

Medical Devices

Medical devices entering the U.S. require FDA establishment registration, device listing, UDI/GUDID submissions, and 510(k) premarket notification for many products.

Services

FDA Medical Device Establishment Registration
Annual U.S. Agent Service for Medical Devices
Medical Device Listing (Per Device)
GUDID Account Creation Assistance
UDI Device Submission to GUDID (Up to 5 Devices)
Primary / Secondary Device Label Review
Instructions for Use (IFU) / User Manual Review
FDA 510(k) Premarket Notification
FDA Small Business Application

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FDA registration & listing
Annual U.S. agent
GUDID/UDI submission
510(k) premarket notification

Product compliance and market-entry operations

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