Others titles
- Medical Device Manufacturers
- MD Manufacturers Identified by Importers
Keywords
- Medical Device Manufacturers
- MD Manufacturers
- Medical Device Importers
Medical Device Manufacturers Identified by Importers
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.
Get The Data
- ResearchNon-Commercial, Share-Alike, Attribution Free Forever
- CommercialCommercial Use, Remix & Adapt, White Label Log in to download
Description
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.
About this Dataset
Data Info
Date Created | 2013 |
---|---|
Last Modified | 2024-04-15 |
Version | 2024-04-15 |
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 |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Importer_Manufacturer_Id | The importer manufacturer ID | integer | level : Nominalrequired : 1 |
Registration_Key | The Registration Key | integer | level : Nominalrequired : 1 |
Manufacturer_Registration_Key | Medical device manufacturer registration key | integer | level : Nominalrequired : 1 |
Registration_Key_Value | Key value related to Registration Listing ID of the Establishment | integer | level : Nominalrequired : 1 |
Data Preview
Importer Manufacturer Id | Registration Key | Manufacturer Registration Key | Registration Key Value |
294737 | 323855 | 16 | 1750139873 |
294703 | 323855 | 16 | 1424051656 |
168308 | 219886 | 16 | 1797873423 |
294704 | 323855 | 16 | 1890153802 |
294705 | 323855 | 16 | 1676980042 |
294706 | 323855 | 16 | 1912833564 |
294707 | 323855 | 16 | 1258595950 |
294709 | 323855 | 16 | 1093058483 |
294710 | 323855 | 16 | 1625197804 |
294712 | 323855 | 16 | 1379515430 |