Medical Device Registration

$179 / year

Detailed list of the types of device establishments that are required to register and pay the fee can be found in this dataset. This dataset also contains Medical Device Establishment Registration Information including registration keys and full addresses of establishments.

Complexity

Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), Premarket Approval (PMA), Product Development Protocol (PDP), Humanitarian Device Exemption (HDE)).
The amendments to the Medical Device User Fee Modernization Act require that after September 30th, 2007, all registration and listing information be submitted electronically, unless a waiver has been granted. The establishment registration fee is not eligible for a reduced small business fee.

Registration and listing provide FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.

Date Created

2013

Last Modified

2019-06-24

Version

2019-06-24

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

Establishment Registration MD, Establishment Registration, MD Registration, Medical Device Establishments, MD Establishment Listing

Other Titles

Medical Device Establishment Registration, MD Establishment Registration

NameDescriptionTypeConstraints
Registration_KeyRegistration Key of the Establishmentintegerrequired : 1 level : Nominal
Registration_NumberRegistration Number of the Establishmentintegerlevel : Nominal
FEI_NumberFacility Establishment Identifier Numberintegerlevel : Nominal
Registration_Status_IDRegistration status IDintegerenum : Array level : Nominal
Is_Initial_Importer_FlagInitial importer flagboolean-
Registration_Expiry_DateRegistration expiry yeardate-
Address_TypeEstablishment Address typestringenum : Array
NameName of the Establishmentstring-
Address_Line_1Address of the Establishment, 1st linestring-
Address_Line_2Address of the Establishment, 2nd linestring-
CityCity of the Establishmentstring-
State_AbbreviationState code of the Establishmentstring-
Iso_Country_CodeCountry of the Establishmentstringrequired : 1
Zip_CodeZip code of the Establishmentstring-
Postal_CodePostal code of the Establishmentstring-
Registration KeyRegistration NumberFEI NumberRegistration Status IDIs Initial Importer FlagRegistration Expiry DateAddress TypeNameAddress Line 1Address Line 2CityState AbbreviationIso Country CodeZip CodePostal Code
63791057944.03001452772.01True2019FSAFILO USA, INC.5201 BLUE LAGOON DR.STE 130DoralFLUS33126.0
71812433092.02433092.01True2019FFINE SURGICAL, INC.50-54 Polk AvenueHEMPSTEADNYUS11550.0
72911058258.01000307645.01True2019FRICHEMONT LATIN AMERICA & CARIBBEAN LLC550 Biltmore Way PH1CORAL GABLESFLUS33134.0
61642183741.02183741.01False2019FGENESIS INDUSTRIES, INC.601 PRO-JECT DR.ELMWOODWIUS54740.0
61512184002.01000115753.01False2019FLIFECORE BIOMEDICAL, LLC3515 LYMAN BLVD.CHASKAMNUS55318.0
63352222003.01000150265.01False2019FWHITEHALL/A DIVISION OF ACORN ENGINEERING CO.15125 PROCTOR AVECITY OF INDUSTRYCAUS91746.0
90551038749.01038749.01True2019FKARL STORZ ENDOSCOPIA LATINO AMERICA, INC.815 N.W. 57TH AVE., STE. 480MIAMIFLUS33126.0
90573006546082.03006546082.01False2019FKARL STORZ SE & CO. KGELSA-BRANDSTROEM-WEG 21TUTTLINGEN Baden-WurttembergDE78532.0
89641000378975.01000378975.01False2019UShannon McMurrey13515 N Stemmons FwyDallasTXUS75234.0
90373004443427.03004443427.01False2019FSEPTODONT HEALTHCARE INDIA PRIVATE LTD.C-1/2 MIDC INDUSTRIAL AREATALOJAVILLAGE-NAVADE, TALUKA-PANVEL MaharashtrIN410208.0