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U.S. Department of Health and Human Services

Medical Devices

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Establishment Registration and Medical Device Listing Files for Download

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
  • Name
  • 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