# FDA-Registered Medical Device Establishments Outside the U.S. — 107 countries outside the U.S. location dataset

All 15,521 locations in 107 countries outside the U.S., as one CSV: 46 fields per record, file built October 26, 2026. $69 one-time, with up to 10 real rows free before you buy.

Canonical URL: https://locationlists.com/data/foreign-fda-registered-medical-device-manufacturer-list

15,521 medical device sites outside the U.S. with an active FDA registration, read on 26 October 2026 from FDA's device registration and listing files. These are the plants that make, sterilize or export devices sold in the U.S. China has 5,065, Germany 1,084, South Korea 894, Canada 658, the U.K. 625 and Taiwan 623, out of 107 countries. 11,342 are registered as manufacturers, 5,131 as contract manufacturers and 4,027 as foreign exporters. Each row has the product codes with device class and implant flags, 510(k) and PMA numbers, the owner/operator, FDA's official correspondent with a phone, and the site's U.S. agent with company (12,323 rows), phone and email. Medical devices and PPE are under a Section 232 national security investigation (opened September 2025).

## The figures

- Records: 15,521 locations
- Coverage: 107 countries outside the U.S.
- Fields: 46
- Price: $69 one-time, CSV download, commercial license (https://locationlists.com/license)
- Snapshot built on October 26, 2026. Not rebuilt on a schedule.
- File last modified: 2026-10-26

The file has all 15,521 locations in one download. Building the same list by searching one area at a time tends to miss places, and a missed place looks like a gap in coverage that is not really there.

## Fields

- `name`: Establishment name as registered with FDA (all-capitals names set in title case)
- `ownerOperator`: Owner or operator firm FDA lists for the registration
- `ownerOperatorNumber`: FDA owner/operator number (groups a firm's sites)
- `establishmentTypes`: FDA establishment types: Manufacturer, Contract Manufacturer, Specification Developer, Repackager/Relabeler, Contract Sterilizer, Foreign Exporter and others
- `establishmentTypeCount`: How many establishment types the site holds
- `manufacturer`: Y when the site makes, contract-makes, sterilizes or repackages devices
- `productCodes`: FDA product codes the site lists, space-separated
- `productCodeCount`: How many product codes the site lists
- `deviceClasses`: Listed products by FDA device class (e.g. class2:14)
- `anyImplant`: Y when a listed product code is an implant
- `anyLifeSustaining`: Y when a listed product code is life-sustaining or life-supporting
- `premarketSubmissions`: 510(k), PMA and De Novo numbers on the site's listings
- `address`: Street address of the site
- `city`: City
- `zip`: ZIP or postal code
- `country`: Country (U.S. lists: US)
- `contactName`: Contact person FDA publishes for the site (drugs: establishment contact; devices: official correspondent)
- `contactCompany`: Company of the official correspondent, where it differs
- `phone`: Official correspondent's phone
- `ownerAddress`: Owner/operator street address
- `ownerCity`: Owner/operator city
- `ownerState`: Owner/operator state or province
- `ownerZip`: Owner/operator ZIP or postal code
- `ownerCountry`: Owner/operator country code
- `usAgentName`: U.S. agent's contact name
- `usAgentCompany`: U.S. agent's company
- `usAgentPhone`: U.S. agent's phone
- `usAgentEmail`: U.S. agent's email
- `initialImporter`: Y when the site is registered as an initial importer
- `registrationNumber`: FDA registration number
- `fdaRegKey`: FDA's record key for the registration
- `feiNumber`: FDA Establishment Identifier (FEI)
- `registrationYear`: Year the registration is current through
- `section232Sector`: Section 232 investigation the site falls under (pharmaceuticals; medical devices and PPE)
- `nameAsPublished`: Establishment name exactly as FDA writes it
- `sourceUrl`: FDA's public search page for the register (devices: the registration's own page)
- `sourceFile`: FDA bulk file the row was read from
- `sourceDate`: Date of the FDA file
- `rowId`: Row id: the site's DUNS number (drugs) or FDA's registration record key (devices)
- `directionsUrl`: Google Maps directions link to the site
- `naicsCode`: NAICS code (drugs 325412, devices 339112)
- `naicsTitle`: NAICS title
- `sicCode`: SIC code (drugs 2834, devices 3841)
- `sicTitle`: SIC title
- `updatedDate`: Date the list was built
- `address_quality`: complete, no_house_number, po_box, missing_city_or_zip or missing

In the header but under 1% filled, so not in this release: state.

## What we did to this data

Fixed 3 doubled addresses, flagged 11,900 incomplete addresses and measured 15,521 rows. Rebuilt October 26, 2026 from accessdata.fda.gov.

## How complete the key fields are

phone 100%, street address 100%, city 100%, state 0%, ZIP code 100%. 44 of 47 columns are filled on at least half the rows.

## Ask this list a question with a link

No connector and no account; each link answers with the matching count, preview rows and the price for just that part.

- [Only rows where manufacturer is Y](https://locationlists.com/find?dataset=foreign-fda-registered-medical-device-manufacturer-list&where=manufacturer%3Aeq%3AY)
- [The whole list: add a city, state, ZIP code or distance](https://locationlists.com/find?dataset=foreign-fda-registered-medical-device-manufacturer-list)

## The same dataset, for machines

- Record as JSON: https://locationlists.com/data/foreign-fda-registered-medical-device-manufacturer-list/dataset.json
- Free sample, up to 10 real rows: https://locationlists.com/data/foreign-fda-registered-medical-device-manufacturer-list/sample.csv or https://locationlists.com/data/foreign-fda-registered-medical-device-manufacturer-list/sample.json
- Buy link (opens Stripe Checkout): https://locationlists.com/data/foreign-fda-registered-medical-device-manufacturer-list/buy

## Questions

### Which sites are in it?

Every registration outside the U.S. that FDA marks active in its device files on 26 October 2026. One row is one registration record.

### What is the U.S. agent?

FDA requires every foreign device site to name an agent in the U.S. The usAgent columns have the agent's name, company, phone and email as FDA publishes them.

### Do foreign rows have map points?

No. The address is as FDA publishes it, with the country code. We do not geocode foreign addresses.

### How current is the data?

Snapshot built on October 26, 2026. It is a one-time snapshot and is not rebuilt on a schedule.

### How is this data cleaned?

Every rebuild runs the same steps and counts what each one changed. For the current file, rebuilt October 26, 2026 from accessdata.fda.gov: Merged 0 duplicate listings that had the same business name, street address and ZIP code, keeping every filled-in detail from both (October 26, 2026). Unified 0 city names written more than one way within the same ZIP code (for example with and without a space or an abbreviation) to the US Census Bureau spelling (October 26, 2026). Corrected 0 misspelled city names to the US Census Bureau place name for their ZIP code (October 26, 2026). Removed the second copy of 3 street addresses that were typed twice in the same field (October 26, 2026). Added map coordinates to 0 listings that had none, from the US Census Bureau address geocoder or, where the street address could not be matched, the centre of the ZIP code (October 26, 2026). Set the county and its federal county code on 0 listings, matched to the US Census Bureau county list from the county the source records, the listing's map point, or its ZIP code area (October 26, 2026). Checked every map point against the state in its address and re-placed 0 points that fell outside that state (October 26, 2026). Flagged 11,900 addresses that are incomplete, a PO box, or missing a house number, in an address quality column (October 26, 2026). Checked that the row count, state count and field completeness published for this file were measured from the file itself (October 26, 2026).

### Isn't this free on accessdata.fda.gov?

The underlying records are public on accessdata.fda.gov. What you pay for is the work between that public release and this file: fixed 3 doubled addresses, flagged 11,900 incomplete addresses and measured 15,521 rows. The current file was rebuilt October 26, 2026 from accessdata.fda.gov. Doing it yourself means downloading the full release, repeating each of those steps, and repeating them again every time the source updates.

### How complete is each field?

Measured on every row of the current file, the share of rows that carry each key field: phone 100%, street address 100%, city 100%, state 0%, ZIP code 100%. 44 of 47 columns are filled on at least half the rows, and 1 is empty in every row.