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fda registration services

Domestic and foreign companies that are involved in the production and distribution of medical devices or drug products intended for use in the United States, are required to register annually with the U.S. Food and Drug Administration (U.S. FDA). This process is known as establishment registration.

Join thousands of satisfied clients in more than 100 countries. Reach millions more customers willing and able to buy your products.

ITB HOLDINGS LLC assists companies around the world, including manufacturers, exporters, importers of N95 respirators, ventilators, personal protective equipment (PPE), hand sanitizers, and other products covered by the Emergency Use Authorization (EUA) .

Are you exporting or importing conventional food products, dietary supplements, canned food, instead? Simply contact us.

Registration Services

For Domestic and Foreign Companies


■ Establishment registrations are based on FDA’s fiscal year which runs from October 1 to September 30.
■ Domestic and foreign companies are required to have a DUNS (Data Universal Numbering System) Number issued by Dun & Bradstreet Inc to all types of business organizations including sole proprietorships, corporations, partnerships, non-profits, and government entities.

    FDA approved Pradaxa oral pellets, to prevent recurrent clots among patients 3 months to less than 12 years old,  who completed treatment for their first venous thromboembolism (a condition where blood clots form in the veins), directly after they have been treated with a blood thinner given by injection for at least five days.

    FDA issued a Drug Safety Communication for hand sanitizers, warning that symptoms such as headache, nausea, and dizziness can occur after applying alcohol-based hand sanitizers to the skin and inhaling the vapors that linger.

    On July 22, 2021, the FDA issued an Emergency Use Authorization (EUA) for specific sodium citrate tubes in health care settings to collect, transport, and store blood specimens for coagulation testing to aid in the identification and treatment of coagulopathy in patients with known or suspected COVID-19, with testing performed by authorized laboratories.


    Exporting Hand Sanitizers or PPEs?
    Contact ITB HOLDINGS LLC, today, to register your company and list your products, with extra savings
    Don’t take a chance assuming that regulations in the United States, Canada, Mexico, Brazil, Australia, India, South Korea, China, Japan, Russia, European Union, are the same or similar.
    Food Facilities
    Medical Devices (PPEs)
    OTC Drugs (Hand Sanitizers)