FDA Registration Number Lookup — Quick Steps

You can search an FDA registration number using official FDA databases by following these steps:

1. Go to the FDA Establishment Registration database
2. Enter the company or facility name
3. Locate the FEI (Facility Establishment Identifier)
4. Confirm registration status and details

👉 Official FDA database: Establishment Registration & Device Listing

How do I search for an FDA Registration Number?

The answer depends on the type of product in question. The FDA maintains searchable databases for some product categories, while others—like food facilities—do not have public access to registration details.

Below, we break down the process by product type and provide step-by-step instructions on how to search FDA registration numbers when possible.

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Medical Devices

For medical device establishments, the FDA maintains a publicly searchable database that lists registered companies and their devices.

Steps to Search for a Medical Device Registration Number:

1. Go to the FDA Establishment Registration & Device Listing database:
   https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
2. Search by any of the following criteria:

   • Company Name
   • Product Name
   • Owner/Operator Number
   • Establishment Registration Number
   • City, State, or Country

3. Review the search results:

   • You’ll see a list of registered companies, their establishment types, products, and registration status.
   • The FDA Registration Number will be listed along with the company details.

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Drug Establishments

The FDA also provides a searchable database for drug establishments that manufacture, repack, or relabel human or animal drugs.

Steps to Search for a Drug Establishment Registration:

1. Visit the FDA Drug Establishments Current Registration Site:
   https://www.accessdata.fda.gov/scripts/cder/drls/default.cfm
2. Search by:

   • Establishment Name
   • Drug Name
   • National Drug Code (NDC)
   • City, State, or Country

3. View the results:

   • You’ll find the registration details, status, and relevant identification numbers.

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Food Facilities

Unlike medical device and drug facilities, FDA Food Facility Registration Numbers are not publicly searchable.

Due to confidentiality provisions under the Bioterrorism Act of 2002, the FDA does not provide an open database for food facility registrations.

How to Verify a Food Facility Registration:

• Only the FDA and the registered facility have access to the registration number.
• If you’re an importer or business partner, the facility may need to share their registration confirmation with you directly.
• Customs and FDA can verify this during the Prior Notice and import process.

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⚠️ Important Notes

• An FDA Registration Number is not an FDA approval. It simply confirms that a company or facility is registered with the FDA, not that their products are FDA-approved.
• Always verify the registration status and check if the facility or product is active, compliant, and up-to-date.
• If in doubt, you may contact the FDA or consult a regulatory consultant for official verification.

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Summary

Product Type	Publicly Searchable?	Search Method
Medical Devices	✅ Yes	FDA Device Registration Database
Drug Establishments	✅ Yes	FDA Drug Registration Database
Food Facilities	❌ No	Facility must provide registration details directly

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Need Help Navigating FDA Regulations?

If you’re unsure how to proceed with FDA registration or verification, it’s best to consult a regulatory expert who can guide you through the process and ensure compliance.