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In this section: 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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