Others titles
- Medical Device Registered Importers
- MD Registered Importers
- MD Registered Importers Identified by Manufacturers
Keywords
- Registered Importers
- Medical Device Importers
- MD Identified Manufacturers
Medical Device Registered Importers Identified by Manufacturers
This dataset contains details of Medical Device Importers. Establishments that are required to register with the Food and Drug Administration (FDA) are also required to list the devices that are made there and the activities that are performed on those devices.
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Description
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 | 2024-06-10 |
Version | 2024-06-10 |
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 | Registered Importers, Medical Device Importers, MD Identified Manufacturers |
Other Titles | Medical Device Registered Importers, MD Registered Importers, MD Registered Importers Identified by Manufacturers |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Registration_Key_Value | Key value related to registration listing ID of the establishment | integer | level : Nominalrequired : 1 |
Importer_Registration_Key | The medical device importer registration key | integer | level : Nominalrequired : 1 |
Establishment_Registration_Key | The establishment registration key | integer | level : Nominal |
Data Preview
Registration Key Value | Importer Registration Key | Establishment Registration Key |
1651424905 | 323855 | 16.0 |
1673148225 | 323855 | 16.0 |
1103542434 | 219886 | 16.0 |
1522527140 | 323855 | 16.0 |
1037529483 | 323855 | 16.0 |
1327178070 | 323855 | 16.0 |
1912833564 | 323855 | 16.0 |
1168674909 | 323855 | 16.0 |
1204978297 | 58743 | 16.0 |
1258595950 | 323855 | 16.0 |