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  6. Establishment Registration and Medical Device Listing Files for Download
  1. Device Registration and Listing

Establishment Registration and Medical Device Listing Files for Download

Download Files (compressed pipe-separated text files) - files are updated every Sunday night

Download File Layout

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

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
  • Premarket Submission Number

Contact Addresses

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

Non-Registered Importers Identified by Manufacturers

  • Establishment Registration key
  • File ID
  • Importer Address ID
  • DUNS Number
  • Business Name
  • Address Line 1
  • Address Line 2
  • State
  • Zip Code
  • Country
  • Email Address
  • Business Phone Area Code
  • Business Phone
  • Business Phone Extension
  • FAX Area Code
  • FAX Number
  • Importer Type
  • Subdivision Code
  • Postal Code
  • Business Phone Country Code
  • FAX Country Code

Manufacturers Identified by Importers

  • Importer Manufacturer ID
  • Registration Key
  • Manufacturer Registration key
  • File ID

Registered Importers Identified by Manufacturer

  • File ID
  • Importer Registration Key
  • Establishment Registration Key
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
 
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