U.S. Food and Drug Administration - CDRH Mobile
Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website
FDA Home Page | CDRH Home Page | Search | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
horizonal rule

Establishment Registration and Medical Device Listing Files for Download

Download Files (compressed pipe-seperated text files)

Download File Layout

Contact Addresses

  • Address ID
  • Contact ID
  • Address Line1
  • Address Line2
  • City
  • State Code
  • State Province
  • ISO Country Code
  • Postal Code

Registration

  • Registration key
  • Registration number
  • Registration status id
  • Initial importer flag
  • Registration expiry date year
  • Address type id
  • Name
  • Address line 1
  • Address line 2
  • City
  • State id
  • ISO country code
  • Zip code
  • Postal code

Listing Establishment Types

  • Registration Key
  • Registration listing Id
  • Establishment Type Id

Owner Operator

  • Registration Key
  • Contact ID
  • Firm Name
  • Owner Operator Number

US Agent

  • Registration key
  • title id
  • Name
  • Organization Title
  • Business Name
  • Bus Phone Area Code
  • Bus Phone Num
  • Bus Phone Extn
  • Fax Area Code
  • Fax Num
  • Email Address

Listing Proprietary Name

  • Listing prop name id
  • File ID
  • Proprietary name

Establishment Types

  • Establishment Type Id
  • Establishment Description
  • Establishment Short Description

Listing PCD

  • File ID
  • Product code
  • created date
  • Owner operator number
  • Exempt

Official Correspondent

  • Registration Key
  • Contact ID
  • First Name
  • Middle Initial
  • Last Name
  • Subaccount Company Name
  • Phone Number

Registration Listing

  • Registration listing id
  • Registration key
  • File ID
ESTABLISHMENT
TYPE ID
ESTABLISHMENT DESCRIPTION
1 Manufacture Medical Device for Another Party (Contract Manufacturer)
2 Sterilize Medical Device for Another Party (Contract Sterilizer)
3 Export Device to the United States But Perform No Other Operation on Device
4 Initial Distributor/Importer
5 Manufacture Medical Device
6 Remanufacture Medical Device
7 Repack or Relabel Medical Device
8 Reprocess Single-Use Device
9 Develop Specifications But Do Not Manufacture At This Facility
10 Manufacture Device in the United States for Export Only

Updated September 26, 2008

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH