Establishment Registration and Medical Device Listing Files
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Medical Device Establishment Contact Addresses dataset contains address details of medical device establishments including full address and postal codes listed by Adress ID. Initia...
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Medical Device Establishment Official Correspondent dataset contains Medical Device Establishment Registration Official Correspondent Information including full names and phone nu...
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All registration information must be verified annually between October 1st and December 31st of each year. In addition to registration, foreign manufacturers must also designate a ...
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Establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. Medical ...
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Information about a foreign establishment’s U.S. agent is submitted electronically using the FDA Unified Registration and Listing System (FURLS) system and is part of the establ...
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Medical Device Listing Establishment Listing Types contains Establishment Type ID of each Establishment linked to Registration Key and Registration Listing ID. All registration inf...
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Classification product codes are a key element in the reporting of adverse events and product problems in medical device reports (MDRs). Though not clearly requested in the 3500A m...
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Medical Device Listing Proprietary Name contains the Proprietary Name linked to registration key and Listing Proprietary Name Id. Proprietary names may be uploaded from Excel sprea...
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Medical Device Manufacturers Identified by Importers dataset contains details of Medical Device Manufacturers including Manufacturer registration key. Foreign manufacturers must me...
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Medical Device Non-Registered Importers Identified by Manufacturers dataset contains details of Non-Registered Importers of medical devices including full address and phone numbers...