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

2019-04-08

Version

2019-04-08

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
1336951443HILCO1218954
6929962616Talon2427635
6931962616Talon2427635
94502646603SECA8010918
94512646603SECA8010918
587392085812WAM9044806
671101006442ACI9090879
497949699ASO LLC1038758
498949699ASO LLC1038758
6012072000CITMED1043545