Medical Device Manufacturers Identified by Importers

$179 / year

This dataset shows foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories. In order to import medical devices and/or products that emit radiation into the U.S., the product must meet FDA regulatory requirements. Food and Drug Administration (FDA) does not recognize regulatory approvals from other countries.

Complexity

Medical Device Manufacturers Identified by Importers dataset contains details of Medical Device Manufacturers including Manufacturer registration key. Foreign manufacturers must meet applicable United States (U..S.) medical device regulations in order to import devices into the U.S. even if the product is authorized for marketing in another country. These requirements include registration of establishment, listing of devices, manufacturing in accordance with the quality system regulation, medical device reporting of adverse events, and Premarket Notification 510(k) or Premarket Approval, if applicable. In addition, the foreign manufacturers must designate a United States agent. As with domestic manufacturers, foreign manufacturing sites are subject to FDA inspection. Information on U.S. regulatory requirements can be found in the Device Advice section.

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

Medical Device Manufacturers, MD Manufacturers, Medical Device Importers

Other Titles

Medical Device Manufacturers, MD Manufacturers Identified by Importers

NameDescriptionTypeConstraints
Importer_Manufacturer_IdThe importer manufacturer IDintegerrequired : 1 level : Nominal
Registration_KeyThe Registration Keyintegerrequired : 1 level : Nominal
Manufacturer_Registration_KeyMedical device manufacturer registration keyintegerrequired : 1 level : Nominal
Registration_Key_ValueKey value related to Registration Listing ID of the Establishmentintegerrequired : 1 level : Nominal
Importer Manufacturer IdRegistration KeyManufacturer Registration KeyRegistration Key Value
157615207709161997862402
157616207709161976915075
157617207709161050015389
168308219886161797873423
157551207709161172496999
157552207709161053970951
157553207709161968663730
157554207709161129102376
157555207709161212068735
157556207709161896786840