Medical Device Establishment

Get Your Medical Devices Cleared for the U.S. Market

To legally manufacture, import, distribute, or relabel medical devices for the U.S. market, your company must register as a medical device establishment with the FDA. This requirement is mandated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) Section 510 (21 U.S.C. § 360) and detailed in 21 CFR Part 807.

Registration ensures your establishment appears in the FDA’s official database, which supports regulatory oversight, product safety, and supply chain transparency. Annual registration is required, along with device listings for each product you intend to market.

At Hykkon, we simplify this process by helping you:

Complete and submit your FDA Establishment Registration
Obtain a DUNS or EIN number if needed
Serve as your U.S. Agent/Official Correspondent for foreign facilities
Prepare device listings and manage annual renewals
Conduct optional label reviews to meet FDA requirements

What You’ll Need to Provide

Establishment name, address, DUNS/EIN number, and contact details
Type of operation (e.g., manufacturer, contract manufacturer, foreign exporter, contract sterilizer, relabeler, specification developer, initial importer)
U.S. importer/distributor details (for foreign facilities) or manufacturer details (for U.S. facilities)
Proprietary names, common names, device class numbers, and device codes (510(k)) for each device you intend to list

Service Options

FDA Registration Fees

The FDA requires an annual registration fee, which must be paid directly to the FDA. Additional service fees may apply for device listings and label reviews.

Ready to register your medical device establishment?

Complete the form below and let Hykkon handle your FDA submissions quickly and accurately.

We’ll help keep your devices compliant, avoid costly delays, and get you into the U.S. market with confidence.