Medical Device Establishment Owner Operator

$179 / year

The U.S. Food and Drug Administration (FDA) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. For devices that are exempt from Premarket Notification, Manufacturers (both domestic and non-U.S.) and initial distributors (importers) of medical devices must register their establishments with the U.S. FDA.
The operators of such establishments are found in this dataset.

Complexity

All registration information must be verified annually between October 1st and December 31st of each year. In addition to registration, foreign manufacturers must also designate a U.S. Agent. Beginning October 1, 2007, most establishments are required to pay an establishment registration fee. The new U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) imposes many Medical Device Establishment Registration and Listings requirements, effective October 1, 2012.

This official list of operator is updated weekly according to FDA releasing.

Date Created

2013

Last Modified

2019-09-23

Version

2019-09-23

Update Frequency

Weekly

Temporal Coverage

N/A

Spatial Coverage

United States

Source

John Snow Labs; U.S. Food and Drug Administration (FDA);

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

Owner Operator MD, Establishment Owner Operator, Medical Device Operators, Medical Device Establishment Owners

Other Titles

Medical Device Owner Operator, MD Establishment Owner Operator

NameDescriptionTypeConstraints
Registration_KeyRegistration Key of the Establishmentintegerrequired : 1 level : Nominal
Contact_IdContact Idintegerlevel : Nominal
Firm_NameFirm Namestring-
Owner_Operator_NumberOwner Operator Numberstring-
Registration KeyContact IdFirm NameOwner Operator Number
5948632BARNHARDT MFG. CO.1010842
6948632BARNHARDT MFG. CO.1010842
163395481CORDIS CORPORATION1016427
173395481CORDIS CORPORATION1016427
21948646MEDICAL SPECIALTIES, INC.1016498
512916370Smith & Nephew, Inc.1020279
552916370Smith & Nephew, Inc.1020279
79948692PROFESSIONAL PRODUCTS, INC.1026765
1452926635HEIDELBERG MEDICAL, INC.1031128
1551954733PETER BRASSELER HOLDINGS, L.L.C.1032227