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Establishment Registration and Medical Device Listing Files for Download

The files listed below are the Freedom of Information (FOI) Releasable Establishment Registration and Device Listing Files. You can download any or all of these files. An On-Line Search Mechanism is available for Establishment Registration information and Device Listing information . For general information on Registration and Listing visit the CDRH web site at http://www.fda.gov/cdrh/reglistpage.html .

• This FOI information consists of three files. The three files are linked based on the Establishment Registration Number *.
• These files are replaced monthly, usually on the 5th of each month.
• The table below contains the File sizes which are approximate and a file description for each file. The files description contains an explanation of some of the codes used in the file.
• The format is a delimited file (delimited by a | or "pipe" ). A | or "pipe" is a character that marks the end of a field. The end of each record is marked by a paragraph marker or ¶. The length of each field in the data is variable. The maximum length for each field is shown in the table below.
• You can download any or all of the following zipped files. The general steps are:
  1. uncompress the file with WinUnzip, PKUnzip, or other utility;
  2. rename file: filename.lis to filename.txt.
  3. If the file is to be imported into a database, the end-of-record marker is the ¶ symbol

(*) If the Establishment Registration Number is less than 7 characters in length it is not an official Establishment Registration Number but is used only for linking information in the Establishment and Device listing files. Official Establishment Registration Numbers may be either 7 or 10 characters in length.

Updated April 29, 2004

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