Medical Devices

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
11 Complaint File Establishment per 21 CFR 820.198
12 Foreign Private Label Distributor

 

Page Last Updated: 05/12/2015
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