FDA-Registered Medical Device Establishments Outside the U.S.
107 countries outside the U.S. · 15,521 locations
There are 15,521 FDA-Registered Medical Device Establishments Outside the U.S. in 107 countries as of October 2026.
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.
More about this list
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).
Need just some of them? Ask in your own words.
●Where the rows are
≡Sample Data Preview
| name | address | city | state | zip | phone | owner operator | owner operator number | establishment types | establishment type count | manufacturer | product codes | product code count | device classes | any implant | any life sustaining | premarket submissions | contact name | contact company | owner address | owner city | owner state | owner zip | owner country | us agent name | us agent company | us agent phone | us agent email | initial importer | registration number | fda reg key | fei number | registration year | section232 sector | name as published | source file | source date | row id | directions url | naics code | naics title | sic code | sic title | updated date | address quality | country | source url |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rediston LTD. | Level 15 Nexxus Building 41 Connaught Road Central | - | - | (757) 224-0177 | Rediston Ltd. | 10060989 | Foreign Exporter | 1 | N | JIN | 1 | class1:1 | N | N | David Lennarz | Registrar Corp | David Lennarz | Registrar Corp | (757) 224-0177 | david.lennarz@registrarcorp.com | N | 3015745144 | 231945 | 3015745144 | 2026 | medical devices and PPE | REDISTON LTD. | https://www.accessdata.fda.gov/premarket/ftparea/registration.zip | 2026-10-26 | 231945 | https://www.google.com/maps/dir/?api=1&destination=Level%2015%20Nexxus%20Building%2041%20Connaught%20Road%20Central%2C%20-%2C%20-%2C%20HK | 339112 | Surgical and Medical Instrument Manufacturing | 3841 | Surgical and Medical Instruments and Apparatus | 2026-10-26 | no_house_number | HK | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=231945 | |||||||
| Titan Company Limited | Lens Lab Factory NO 24, 24A | KIADB Industrial Area | Chikkaballapur Karnataka | (757) 224-0177 | Titan Company Limited | 10038594 | Manufacturer | 1 | Y | HQG | 1 | class1:1 | N | N | David Lennarz | Registrar Corp | NO 24, 24A KIADB Industrial Area | Chickballapur | IN-KA | 562101 | IN | David Lennarz | Registrar Corp | (757) 224-0177 | david.lennarz@registrarcorp.com | N | 3009233789 | 134374 | 3009233789 | 2026 | medical devices and PPE | Titan Company Limited | https://www.accessdata.fda.gov/premarket/ftparea/registration.zip | 2026-10-26 | 134374 | https://www.google.com/maps/dir/?api=1&destination=%20Lens%20Lab%20Factory%20NO%2024%2C%2024A%2C%20KIADB%20Industrial%20Area%2C%20Chikkaballapur%20Karnataka%2C%20IN | 339112 | Surgical and Medical Instrument Manufacturing | 3841 | Surgical and Medical Instruments and Apparatus | 2026-10-26 | no_house_number | IN | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=134374 | ||
| Abbott Laboratories (Singapore) Private Limited | 3 Fraser Street #23-28 DUO Tower | - Central Singapore | 189352 | (224) 668-0142 | Abbott Laboratories | 1415939 | Foreign Exporter | 1 | N | GKZ KPA | 2 | class1:2 class2:4 | N | N | K051215 K061667 K220031 K243283 | Sara Qadri | Core Diagnostics | 100 ABBOTT PARK RD. D-03Q3, AP52-1 | Abbott Park | IL | 60064 | US | Sara Qadri | Abbott Laboratories | (224) 668-0142 | sara.qadri@abbott.com | N | 3006412379 | 191533 | 3006412379 | 2027 | medical devices and PPE | Abbott Laboratories (Singapore) Private Limited | https://www.accessdata.fda.gov/premarket/ftparea/registration.zip | 2026-10-26 | 191533 | https://www.google.com/maps/dir/?api=1&destination=3%20Fraser%20Street%20%2323-28%20DUO%20Tower%2C%20-%20Central%20Singapore%2C%20189352%2C%20SG | 339112 | Surgical and Medical Instrument Manufacturing | 3841 | Surgical and Medical Instruments and Apparatus | 2026-10-26 | complete | SG | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=191533 | |
| Probed Medical Technologies, Inc. | 602-30930 WHEEL AVE. | ABBOTSFORD British Columbia | V2T 6G7 | (604) 852-3096 | Probed Medical Technologies, Inc. | 9005712 | Manufacturer | 1 | Y | IKZ | 1 | class2:1 | N | N | STEVE PLUMMER | 602-30930 WHEEL AVE. | Abbotsford | CA-BC | V2T 6G7 | CA | Anthony DaCosta | ProBed Medical | (562) 221-5935 | adacosta@pro-bed.com | N | 8044130 | 45743 | 3005743621 | 2026 | medical devices and PPE | PROBED MEDICAL TECHNOLOGIES, INC. | https://www.accessdata.fda.gov/premarket/ftparea/registration.zip | 2026-10-26 | 45743 | https://www.google.com/maps/dir/?api=1&destination=602-30930%20WHEEL%20AVE.%2C%20ABBOTSFORD%20British%20Columbia%2C%20V2T%206G7%2C%20CA | 339112 | Surgical and Medical Instrument Manufacturing | 3841 | Surgical and Medical Instruments and Apparatus | 2026-10-26 | complete | CA | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=45743 | |||
| LUXOTTICA Group SPA | VIA VALOCOZZENA | AGORDO Belluno | 32021 | (770) 853-1757 | Luxottica of America | 9032320 | Foreign Exporter; Foreign Private Label Distributor; Manufacturer | 3 | Y | HOI HQG HQY HQZ | 4 | class1:4 | N | N | Francesco Iavarone | 100 Greenwood Industrial Pkwy | McDonough | GA | 30253 | US | Domenico Bon | EssilorLuxottica | (949) 900-7458 | dbon@oakley.com | N | 9614827 | 17455 | 3001654059 | 2026 | medical devices and PPE | LUXOTTICA Group SPA | https://www.accessdata.fda.gov/premarket/ftparea/registration.zip | 2026-10-26 | 17455 | https://www.google.com/maps/dir/?api=1&destination=VIA%20VALOCOZZENA%2C%20AGORDO%20Belluno%2C%2032021%2C%20IT | 339112 | Surgical and Medical Instrument Manufacturing | 3841 | Surgical and Medical Instruments and Apparatus | 2026-10-26 | no_house_number | IT | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=17455 |
{}What's in each row
| Field | What it is | Rows filled |
|---|---|---|
| name | Establishment name as registered with FDA (all-capitals names set in title case) | 100% |
| owner | Owner or operator firm FDA lists for the registration | 100% |
| owner | FDA owner/operator number (groups a firm's sites) | 100% |
| establishment | FDA establishment types: Manufacturer, Contract Manufacturer, Specification Developer, Repackager/Relabeler, Contract Sterilizer, Foreign Exporter and others | 100% |
| establishment | How many establishment types the site holds | 100% |
| manufacturer | Y when the site makes, contract-makes, sterilizes or repackages devices | 100% |
| product | FDA product codes the site lists, space-separated | 100% |
| product | How many product codes the site lists | 100% |
| device | Listed products by FDA device class (e.g. class2:14) | 100% |
| any | Y when a listed product code is an implant | 100% |
| any | Y when a listed product code is life-sustaining or life-supporting | 100% |
| premarket | 510(k), PMA and De Novo numbers on the site's listings | 40% |
| address | Street address of the site | 100% |
| city | City | 100% |
| zip | ZIP or postal code | 100% |
| country | Country (U.S. lists: US) | 100% |
| contact | Contact person FDA publishes for the site (drugs: establishment contact; devices: official correspondent) | 100% |
| contact | Company of the official correspondent, where it differs | 22% |
| phone | Official correspondent's phone | 100% |
| owner | Owner/operator street address | 77% |
| owner | Owner/operator city | 77% |
| owner | Owner/operator state or province | 77% |
| owner | Owner/operator ZIP or postal code | 77% |
| owner | Owner/operator country code | 77% |
| us | U.S. agent's contact name | 100% |
| us | U.S. agent's company | 79% |
| us | U.S. agent's phone | 100% |
| us | U.S. agent's email | 100% |
| initial | Y when the site is registered as an initial importer | 100% |
| registration | FDA registration number | 100% |
| fda | FDA's record key for the registration | 100% |
| fei | FDA Establishment Identifier (FEI) | 100% |
| registration | Year the registration is current through | 100% |
| section232 | Section 232 investigation the site falls under (pharmaceuticals; medical devices and PPE) | 100% |
| name | Establishment name exactly as FDA writes it | 100% |
| source | FDA's public search page for the register (devices: the registration's own page) | 100% |
| source | FDA bulk file the row was read from | 100% |
| source | Date of the FDA file | 100% |
| row | Row id: the site's DUNS number (drugs) or FDA's registration record key (devices) | 100% |
| directions | Google Maps directions link to the site | 100% |
| naics | NAICS code (drugs 325412, devices 339112) | 100% |
| naics | NAICS title | 100% |
| sic | SIC code (drugs 2834, devices 3841) | 100% |
| sic | SIC title | 100% |
| updated | Date the list was built | 100% |
| address_ | complete, no house number, po box, missing city or zip or missing | 100% |
Rows filled is measured on every row of the delivered file.
✓Where this data comes from
Each row names the public source it came from, so any record can be checked against where it was published.
October 26, 2026
Snapshot built
47 fields
Columns in the file
Fill measured
On every row of the delivered file
How we build and date every file: methodology.
Using ChatGPT, Claude or an API?
No setup needed. Ask ChatGPT or Claude your question about the FDA-Registered Medical Device Establishments Outside the U.S. and give it this page: it can open https://locationlists.com/find?dataset=foreign-fda-registered-medical-device-manufacturer-list with the filters you need and show you the count and price.
Using ChatGPT or Claude? Tell it to answer from locationlists.com/find — no account, no connector.
How assistants ask
No connector needed. Any AI assistant can answer from this site with a web link, no connector, no account: open https://locationlists.com/find with the question as query parameters.
If a question needs filtering, distance, combining lists or a price, open a /find link: either put the question itself in q=, or build the structured link. The answer does not need an API, a connector or an account.
Simplest, the question itself: https://locationlists.com/find?q=<the question in plain words>
Or set the parts yourself: https://locationlists.com/find?dataset=<slug>&state=<ST>&city=<city>&county=<county>&zip=<zip>&near=<place or zip>&radius=<miles>&where=<column>:<op>:<value>&total=<rows>
Leave out what the question does not need. Distance is radius, in straight-line miles; near can name several places separated by | to reach from any of them. To ask about several lists at once, use datasets with two or more names, or category with a kind of business. To compare two lists, add relate=nearest and the other list with b. in front of its parameters. To count by area, use areas=county (or zip, state, metro). To keep only places whose county, ZIP code, metro area or state meets a Census figure, add area_where (for example county:population>1000000); with areas, per=100000 gives counts per 100,000 residents.
Links an assistant can open, each showing how many rows match, a few 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
Optional: connect for repeat use or wallet payments:
Read https://locationlists.com/skill.md and follow the instructions to connect LocationLists. Then show me the FDA-Registered Medical Device Establishments Outside the U.S. list.Your assistant will walk you through setup and show you the price before you pay.
For developers
Every step below has a no-connector equivalent: https://locationlists.com/find?dataset=foreign-fda-registered-medical-device-manufacturer-list with the same filters as query parameters.
- Connect your agent to
https://locationlists.com/mcp(no key, no signup). - Call
count_locationswithdataset: "foreign-fda-registered-medical-device-manufacturer-list"and any filter — it is free, and returns how many rows match and what they cost. - Fetch the rows with
query_locations: $0.90 per 100 rows from this dataset. Above 7,761 rows, buying the whole file is cheaper.
Paid in USDC over x402 — the agent gets an HTTP 402 with the exact price, signs, and retries. Money moves only after rows are delivered, so a failed or empty query costs nothing. Setup for Claude, Cursor and VS Code
?Frequently Asked Questions
How many FDA-Registered Medical Device Establishments Outside the U.S. are there worldwide?
There are 15,521 FDA-Registered Medical Device Establishments Outside the U.S. in 107 countries as of October 2026.
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.