# Bastion Hale Distributor Index (full description)

> 53,592 licensed medical device establishments in 111 markets, compiled from 8 public regulatory registries and resolved to one row per company per country. Company level only, no personal data. Build of 22 October 2026. Short version: https://bastionhale.com/llms.txt. Human-readable methodology: https://bastionhale.com/methodology/

Publisher: Bastion Hale LLC, Dubai, an independent advisory for medical device companies that sell beyond their home market through distributors. The Index is the free data layer; Bastion Hale does not vouch for any establishment.

## Totals in this build
- Establishments: 53,592
- Markets with at least one establishment: 111
- Channel role (importer, distributor, wholesaler, authorised representative or sponsor): 20,480
- Registration holders without a channel role: 2,316
- Manufacturers or exporters only: 30,796
- Establishments without a segment (no linked device listings): 27,907
- Registries: 8
- Build date: 2026-10-22

## How to cite
Bastion Hale Distributor Index, 22 October 2026. https://bastionhale.com/distributors/
Cite the page you used (country, segment or profile URL) and the build date shown on it, because counts change with every monthly build. When reusing the underlying records, credit the original registry as its licence requires (see Sources).

## URL patterns
- Home and search: https://bastionhale.com/ and https://bastionhale.com/?q=<device description and markets> (the old /distributor-index/ address redirects here)
- Hub with every market: https://bastionhale.com/distributors/
- Country page: https://bastionhale.com/distributors/<country-slug>/ (slug = lowercase English name with hyphens, e.g. united-arab-emirates)
- Country x segment page: https://bastionhale.com/distributors/<country-slug>/<segment-slug>/ (published where the count is 10 or more)
- Establishment profile: https://bastionhale.com/e/<iso2-lowercase>/<id> (id = e_ followed by 12 hex characters)
- Methodology: https://bastionhale.com/methodology/
- Insights: https://bastionhale.com/insights/
- Sitemap index: https://bastionhale.com/sitemap.xml
- Badge for listed companies: https://bastionhale.com/badge/index-badge.svg

## Sources and licences
- EUDAMED economic operator registration, European Commission public API: 27,301 establishments in 33 markets from 32,557 source rows. https://ec.europa.eu/tools/eudamed/. Licence or terms: CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 24,489 establishments in 108 markets from 25,696 source rows. https://open.fda.gov/apis/device/registrationlisting/. Licence or terms: US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 5,947 establishments in 57 markets from 6,618 source rows. https://health-products.canada.ca/mdall-limh/. Licence or terms: Contains information licensed under the Open Government Licence, Canada.
- web (public register): 1,175 establishments in 14 markets from 1,175 source rows. public register. Licence or terms: Public register.
- Saudi Food and Drug Authority licensed establishments list, medical devices: 709 establishments in 1 markets from 725 source rows. https://www.sfda.gov.sa/en/licensed-establishments-list?typeSector=medicalDevices. Licence or terms: Public register.
- nupco (public register): 243 establishments in 1 markets from 251 source rows. public register. Licence or terms: Public register.
- Oman Ministry of Health approved medical device establishments: 107 establishments in 1 markets from 107 source rows. https://www.moh.gov.om/. Licence or terms: Public register.
- Bahrain National Health Regulatory Authority medical device registration list: 38 establishments in 1 markets from 38 source rows. https://www.nhra.bh/Departments/MDR/. Licence or terms: Public register.

## Method
1. Collect. Each registry is downloaded or read in full and cached, so a rerun never hits the source twice for the same page.
2. Normalise. Every source is mapped to one schema: company name, country, city, website, roles, licence numbers, linked device listings and principals. Contact names, personal emails and phone numbers are dropped.
3. Merge. Rows become one establishment per company per country under the merge rule below.
4. Classify. Roles come from the registry's own categories; segments come from the device listings linked to the establishment.
5. Score. Each establishment gets a size score and a completeness score.
6. Publish. Country pages, segment pages, profiles, sample CSVs and the search shards are rebuilt from the same export, so every number on the site comes from one build.

Merge rule: two rows are the same establishment only when the country is identical and the normalised name is identical. Normalising folds accents, lowercases, removes dots and apostrophes (so S.A. and SA match), turns other punctuation into spaces and strips trailing legal forms such as GmbH, Ltd, LLC, Inc, SA, BV, AG, Srl, SpA, Pty, FZE, WLL and the words they leave behind. A leading Arabic Al is kept on purpose. Nothing is merged across countries, and rows without a country are never merged.
- Name: the longest source name.
- Roles, segments, principals, licence numbers, sources: the union across all merged rows.
- Website and city: the first non-empty value by source priority (EUDAMED, US FDA, Health Canada, then the rest).
- Products listed: summed within each source, then the maximum across sources, because every registry counts the same devices.
- Registrations: summed within each source, then summed across sources, because a Canadian licence and an FDA registration are different registrations.
- Merge confidence: 1.0 when the names already agreed before legal forms were stripped, 0.8 when they matched only after.
The rule is conservative on purpose: the same company filed under two different names counts twice, but two different companies are never folded into one.

## Roles (an establishment can hold several)
- importer: 17,533 establishments. Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence.
- distributor: 2,783 establishments. Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH).
- wholesaler: 555 establishments. Licensed as a wholesale dealer where the registry has that category.
- authorised_rep: 2,970 establishments. Represents a foreign manufacturer towards the regulator (EU authorised representative and similar).
- sponsor: 0 establishments. Holds the market entry on behalf of a manufacturer, in markets that use that term.
- holder: 3,358 establishments. Holds device licences or registrations in its own name (Health Canada MDALL licence holder).
- manufacturer: 39,005 establishments. Registered as a manufacturer with an address in this market, including foreign registrations.
- exporter: 4,453 establishments. Registered with the US FDA as an exporter of devices made for export.

Pages group roles into three classes: channel (importer, distributor, wholesaler, authorised representative or sponsor), holder (holds registrations without a channel role) and manufacturer (manufacturer or exporter only). An establishment can hold several roles; the class is the first that applies in that order.

## Segments
Thirteen segments are mapped from the device listings linked to each establishment (US FDA specialty codes and keywords on device names), never from the company name. Establishments without linked device listings have no segment and still count in the market totals.
- SURG (surgery): Surgery and endoscopy, 7,587 establishments
- ORTH (orthopaedics): Orthopaedics, spine and trauma, 3,411 establishments
- CARD (cardiovascular): Cardiovascular, 3,199 establishments
- ENT (ent): Ear, nose and throat, 2,743 establishments
- GIUR (gastro-urology): Gastroenterology, urology and OB/GYN, 4,489 establishments
- DENT (dental): Dental, 4,077 establishments
- ANES (anaesthesia-respiratory): Anaesthesia and respiratory, 3,096 establishments
- MONI (monitoring-neurology): Patient monitoring and neurology, 7,064 establishments
- OPHT (ophthalmic): Ophthalmic, 3,529 establishments
- IVD (ivd): In-vitro diagnostics, 3,460 establishments
- CONS (consumables): General hospital and consumables, 8,062 establishments
- AEST (aesthetics): Aesthetics, dermatology and lasers, 570 establishments
- RADI (imaging-radiology): Imaging, radiology and radiotherapy, 2,485 establishments

## Scores
The size score runs from 0 to 100. It is a log-scaled, weighted blend, so a company with ten times the listings does not score ten times higher, and each part stops growing at a saturation point.
- Products listed: weight 35, full marks at 1,000 devices
- Registrations held: weight 25, full marks at 200 registrations
- Registries it appears in: weight 15, full marks at 5 sources
- Principals represented: weight 15, full marks at 50 manufacturers
- Distinct roles: weight 10, full marks at 5 roles
An establishment with one source, one role and no counts scores about 6.5; only very large establishments approach 100. The score measures registry footprint, not revenue or quality.
Completeness runs from 0 to 5: one point each for a website, an address, at least one segment, at least one principal, and any product or registration count above zero.

## Indexing rules
- Country pages with fewer than 5 establishments are noindex and stay out of the sitemap.
- Segment pages are only published where a country has 10 or more establishments in the segment.
- Profiles with completeness below 2 are noindex but stay reachable from the tables.

## Limits of the data
- Coverage follows the registries. The EU and EEA (EUDAMED), the United States, Canada, Saudi Arabia, Bahrain and Oman have their own registers in the Index. Other markets appear through establishments registered with the US FDA or in EUDAMED with an address there, so their counts lean towards manufacturers and exporters rather than the local channel.
- Names are the registry's own spelling, including its transliterations.
- Registries change weekly and the Index is rebuilt monthly, so a profile can lag its source by up to a month.
- A registry entry shows that a company is licensed, not that it is active, solvent or a good partner. Bastion Hale does not vouch for any establishment.
- No personal data: named individuals are never collected, even when a registry shows them.

## Update cadence
The Index is rebuilt monthly from fresh downloads of every source. Every page shows its build date, every profile shows when each source last saw the establishment, and the sitemap carries the build date as lastmod. This page describes the build of 22 October 2026.

## Every market (largest first)
- United States: 9,881 establishments, 3,097 with a channel role. https://bastionhale.com/distributors/united-states/
- Germany: 5,416 establishments, 2,307 with a channel role. https://bastionhale.com/distributors/germany/
- China: 5,150 establishments, 198 with a channel role. https://bastionhale.com/distributors/china/
- Italy: 3,680 establishments, 1,253 with a channel role. https://bastionhale.com/distributors/italy/
- Canada: 2,745 establishments, 1,960 with a channel role. https://bastionhale.com/distributors/canada/
- France: 2,670 establishments, 1,037 with a channel role. https://bastionhale.com/distributors/france/
- Netherlands: 2,044 establishments, 1,061 with a channel role. https://bastionhale.com/distributors/netherlands/
- Spain: 1,855 establishments, 1,236 with a channel role. https://bastionhale.com/distributors/spain/
- Türkiye: 1,736 establishments, 684 with a channel role. https://bastionhale.com/distributors/turkiye/
- Poland: 1,583 establishments, 838 with a channel role. https://bastionhale.com/distributors/poland/
- Saudi Arabia: 933 establishments, 899 with a channel role. https://bastionhale.com/distributors/saudi-arabia/
- Sweden: 927 establishments, 310 with a channel role. https://bastionhale.com/distributors/sweden/
- Romania: 872 establishments, 702 with a channel role. https://bastionhale.com/distributors/romania/
- South Korea: 862 establishments, 18 with a channel role. https://bastionhale.com/distributors/south-korea/
- Czechia: 861 establishments, 541 with a channel role. https://bastionhale.com/distributors/czechia/
- Belgium: 690 establishments, 365 with a channel role. https://bastionhale.com/distributors/belgium/
- Switzerland: 666 establishments, 9 with a channel role. https://bastionhale.com/distributors/switzerland/
- United Kingdom: 641 establishments, 30 with a channel role. https://bastionhale.com/distributors/united-kingdom/
- Hungary: 636 establishments, 397 with a channel role. https://bastionhale.com/distributors/hungary/
- Ireland: 627 establishments, 416 with a channel role. https://bastionhale.com/distributors/ireland/
- Taiwan: 613 establishments, 19 with a channel role. https://bastionhale.com/distributors/taiwan/
- Denmark: 608 establishments, 236 with a channel role. https://bastionhale.com/distributors/denmark/
- Portugal: 536 establishments, 327 with a channel role. https://bastionhale.com/distributors/portugal/
- Japan: 526 establishments, 13 with a channel role. https://bastionhale.com/distributors/japan/
- Austria: 514 establishments, 249 with a channel role. https://bastionhale.com/distributors/austria/
- Finland: 449 establishments, 199 with a channel role. https://bastionhale.com/distributors/finland/
- Israel: 390 establishments, 6 with a channel role. https://bastionhale.com/distributors/israel/
- India: 378 establishments, 8 with a channel role. https://bastionhale.com/distributors/india/
- Slovenia: 367 establishments, 293 with a channel role. https://bastionhale.com/distributors/slovenia/
- Greece: 338 establishments, 256 with a channel role. https://bastionhale.com/distributors/greece/
- Mexico: 314 establishments, 8 with a channel role. https://bastionhale.com/distributors/mexico/
- Slovakia: 296 establishments, 203 with a channel role. https://bastionhale.com/distributors/slovakia/
- Viet Nam: 271 establishments, 4 with a channel role. https://bastionhale.com/distributors/viet-nam/
- Norway: 253 establishments, 119 with a channel role. https://bastionhale.com/distributors/norway/
- Hong Kong: 249 establishments, 25 with a channel role. https://bastionhale.com/distributors/hong-kong/
- Malaysia: 239 establishments, 6 with a channel role. https://bastionhale.com/distributors/malaysia/
- Croatia: 225 establishments, 180 with a channel role. https://bastionhale.com/distributors/croatia/
- Australia: 202 establishments, 10 with a channel role. https://bastionhale.com/distributors/australia/
- Lithuania: 198 establishments, 131 with a channel role. https://bastionhale.com/distributors/lithuania/
- Pakistan: 172 establishments, 0 with a channel role. https://bastionhale.com/distributors/pakistan/
- Cyprus: 164 establishments, 148 with a channel role. https://bastionhale.com/distributors/cyprus/
- Bulgaria: 160 establishments, 116 with a channel role. https://bastionhale.com/distributors/bulgaria/
- Thailand: 155 establishments, 6 with a channel role. https://bastionhale.com/distributors/thailand/
- Estonia: 136 establishments, 89 with a channel role. https://bastionhale.com/distributors/estonia/
- Latvia: 124 establishments, 97 with a channel role. https://bastionhale.com/distributors/latvia/
- Singapore: 119 establishments, 3 with a channel role. https://bastionhale.com/distributors/singapore/
- Malta: 114 establishments, 97 with a channel role. https://bastionhale.com/distributors/malta/
- Brazil: 112 establishments, 7 with a channel role. https://bastionhale.com/distributors/brazil/
- Oman: 108 establishments, 107 with a channel role. https://bastionhale.com/distributors/oman/
- Northern Ireland: 91 establishments, 63 with a channel role. https://bastionhale.com/distributors/northern-ireland/
- Costa Rica: 66 establishments, 0 with a channel role. https://bastionhale.com/distributors/costa-rica/
- Indonesia: 62 establishments, 1 with a channel role. https://bastionhale.com/distributors/indonesia/
- Cambodia: 50 establishments, 1 with a channel role. https://bastionhale.com/distributors/cambodia/
- Dominican Republic: 42 establishments, 0 with a channel role. https://bastionhale.com/distributors/dominican-republic/
- New Zealand: 42 establishments, 0 with a channel role. https://bastionhale.com/distributors/new-zealand/
- Bahrain: 38 establishments, 38 with a channel role. https://bastionhale.com/distributors/bahrain/
- Luxembourg: 38 establishments, 17 with a channel role. https://bastionhale.com/distributors/luxembourg/
- Iceland: 35 establishments, 23 with a channel role. https://bastionhale.com/distributors/iceland/
- Philippines: 34 establishments, 0 with a channel role. https://bastionhale.com/distributors/philippines/
- Colombia: 33 establishments, 1 with a channel role. https://bastionhale.com/distributors/colombia/
- Liechtenstein: 30 establishments, 14 with a channel role. https://bastionhale.com/distributors/liechtenstein/
- South Africa: 23 establishments, 0 with a channel role. https://bastionhale.com/distributors/south-africa/
- Argentina: 18 establishments, 1 with a channel role. https://bastionhale.com/distributors/argentina/
- United Arab Emirates: 14 establishments, 0 with a channel role. https://bastionhale.com/distributors/united-arab-emirates/
- Sri Lanka: 13 establishments, 0 with a channel role. https://bastionhale.com/distributors/sri-lanka/
- Bangladesh: 12 establishments, 0 with a channel role. https://bastionhale.com/distributors/bangladesh/
- Egypt: 10 establishments, 0 with a channel role. https://bastionhale.com/distributors/egypt/
- Russia: 10 establishments, 0 with a channel role. https://bastionhale.com/distributors/russia/
- Tunisia: 10 establishments, 0 with a channel role. https://bastionhale.com/distributors/tunisia/
- Chile: 8 establishments, 0 with a channel role. https://bastionhale.com/distributors/chile/
- Ukraine: 8 establishments, 0 with a channel role. https://bastionhale.com/distributors/ukraine/
- Panama: 7 establishments, 0 with a channel role. https://bastionhale.com/distributors/panama/
- Peru: 6 establishments, 0 with a channel role. https://bastionhale.com/distributors/peru/
- Guatemala: 5 establishments, 0 with a channel role. https://bastionhale.com/distributors/guatemala/
- Honduras: 5 establishments, 0 with a channel role. https://bastionhale.com/distributors/honduras/
- Morocco: 5 establishments, 0 with a channel role. https://bastionhale.com/distributors/morocco/
- Mauritius: 5 establishments, 1 with a channel role. https://bastionhale.com/distributors/mauritius/
- El Salvador: 5 establishments, 0 with a channel role. https://bastionhale.com/distributors/el-salvador/
- Myanmar: 4 establishments, 0 with a channel role. https://bastionhale.com/distributors/myanmar/ (noindex, thin)
- Ecuador: 3 establishments, 0 with a channel role. https://bastionhale.com/distributors/ecuador/ (noindex, thin)
- Jordan: 3 establishments, 0 with a channel role. https://bastionhale.com/distributors/jordan/ (noindex, thin)
- Kenya: 3 establishments, 0 with a channel role. https://bastionhale.com/distributors/kenya/ (noindex, thin)
- Laos: 3 establishments, 0 with a channel role. https://bastionhale.com/distributors/laos/ (noindex, thin)
- Lebanon: 3 establishments, 0 with a channel role. https://bastionhale.com/distributors/lebanon/ (noindex, thin)
- Monaco: 3 establishments, 0 with a channel role. https://bastionhale.com/distributors/monaco/ (noindex, thin)
- Macao: 3 establishments, 0 with a channel role. https://bastionhale.com/distributors/macao/ (noindex, thin)
- Nicaragua: 3 establishments, 0 with a channel role. https://bastionhale.com/distributors/nicaragua/ (noindex, thin)
- Uruguay: 3 establishments, 0 with a channel role. https://bastionhale.com/distributors/uruguay/ (noindex, thin)
- Barbados: 2 establishments, 0 with a channel role. https://bastionhale.com/distributors/barbados/ (noindex, thin)
- Belarus: 2 establishments, 0 with a channel role. https://bastionhale.com/distributors/belarus/ (noindex, thin)
- Belize: 2 establishments, 0 with a channel role. https://bastionhale.com/distributors/belize/ (noindex, thin)
- Isle of Man: 2 establishments, 0 with a channel role. https://bastionhale.com/distributors/isle-of-man/ (noindex, thin)
- North Macedonia: 2 establishments, 0 with a channel role. https://bastionhale.com/distributors/north-macedonia/ (noindex, thin)
- Paraguay: 2 establishments, 0 with a channel role. https://bastionhale.com/distributors/paraguay/ (noindex, thin)
- Serbia: 2 establishments, 0 with a channel role. https://bastionhale.com/distributors/serbia/ (noindex, thin)
- Samoa: 2 establishments, 0 with a channel role. https://bastionhale.com/distributors/samoa/ (noindex, thin)
- Andorra: 1 establishments, 0 with a channel role. https://bastionhale.com/distributors/andorra/ (noindex, thin)
- Armenia: 1 establishments, 0 with a channel role. https://bastionhale.com/distributors/armenia/ (noindex, thin)
- Bermuda: 1 establishments, 0 with a channel role. https://bastionhale.com/distributors/bermuda/ (noindex, thin)
- Georgia: 1 establishments, 0 with a channel role. https://bastionhale.com/distributors/georgia/ (noindex, thin)
- Haiti: 1 establishments, 0 with a channel role. https://bastionhale.com/distributors/haiti/ (noindex, thin)
- Nigeria: 1 establishments, 0 with a channel role. https://bastionhale.com/distributors/nigeria/ (noindex, thin)
- Nepal: 1 establishments, 0 with a channel role. https://bastionhale.com/distributors/nepal/ (noindex, thin)
- Puerto Rico: 1 establishments, 0 with a channel role. https://bastionhale.com/distributors/puerto-rico/ (noindex, thin)
- Rwanda: 1 establishments, 0 with a channel role. https://bastionhale.com/distributors/rwanda/ (noindex, thin)
- Seychelles: 1 establishments, 0 with a channel role. https://bastionhale.com/distributors/seychelles/ (noindex, thin)
- San Marino: 1 establishments, 0 with a channel role. https://bastionhale.com/distributors/san-marino/ (noindex, thin)
- Trinidad and Tobago: 1 establishments, 0 with a channel role. https://bastionhale.com/distributors/trinidad-and-tobago/ (noindex, thin)
- Uzbekistan: 1 establishments, 0 with a channel role. https://bastionhale.com/distributors/uzbekistan/ (noindex, thin)
- Venezuela: 1 establishments, 0 with a channel role. https://bastionhale.com/distributors/venezuela/ (noindex, thin)
- Vanuatu: 1 establishments, 0 with a channel role. https://bastionhale.com/distributors/vanuatu/ (noindex, thin)

## Sample CSV downloads (top 200 per market, company fields only)
- Saudi Arabia: https://bastionhale.com/distributors/sample/SA.csv
- United Arab Emirates: https://bastionhale.com/distributors/sample/AE.csv
- Germany: https://bastionhale.com/distributors/sample/DE.csv
- United States: https://bastionhale.com/distributors/sample/US.csv
- Canada: https://bastionhale.com/distributors/sample/CA.csv

## Frequently asked questions
Q: How many medical device distributors are in the Bastion Hale Distributor Index?
A: The current build lists 53,592 medical device establishments in 111 markets. 20,480 of them hold a channel role as importer, distributor, wholesaler or authorised representative; the rest are registration holders or manufacturers. Updated 22 October 2026.

Q: Which registries does the Distributor Index use?
A: EUDAMED, US FDA (openFDA), Health Canada, web, SFDA, nupco, Oman MOH, NHRA Bahrain. Every record points back to its source and the date it was last seen. Only official bulk downloads, documented APIs and public register pages are used, within each source's terms.

Q: Is the Distributor Index free to use?
A: Yes. Counts per market and segment, the country pages and the company profiles are free. Three profiles per search are revealed against an email address. For your own device, the paid Next 10 Markets report (€490) ranks ten markets and names up to ten licensed distributors in each.

Q: Does the Distributor Index include contact names or emails?
A: No. The Index holds companies only: name, city, website where the registry gives one, roles, segments, counts and sources. Named individuals are never collected, even when a registry shows them.

Q: How often is the Distributor Index updated?
A: Monthly. The build date is shown on every page; this one was built on 22 October 2026. Registries change weekly, so a profile can lag its source by up to a month.

## Contact
- The Next 10 Markets report (€490, includes a 20-minute call): https://bastionhale.com/market-finder/
- About: https://bastionhale.com/about