Updated 22 October 2026
How the Distributor Index is built
The Bastion Hale Distributor Index lists 53,592 licensed medical device establishments in 111 markets, compiled from 8 public regulatory registries and resolved to one row per company per country. This page sets out the sources and their licences, the merge rule, how roles, segments and scores are derived, what the data leaves out, how often it is rebuilt and how to cite it.
Sources and licences
Only official bulk downloads, documented APIs and public register pages are used, within each source's terms. Nothing comes from private or paid databases.
| Registry | Establishments | Markets | Source rows | Licence or terms |
|---|---|---|---|---|
| EUDAMED economic operator registration, European Commission public API | 27,301 | 33 | 32,557 | CC BY 4.0. Data filtered and reformatted by Bastion Hale. |
| US FDA Establishment Registration and Device Listing, openFDA bulk download | 24,489 | 108 | 25,696 | US government work, public domain. |
| Health Canada MDALL active licence listing and MDEL establishment licence listing | 5,947 | 57 | 6,618 | Contains information licensed under the Open Government Licence, Canada. |
| web (public register) | 1,175 | 14 | 1,175 | Public register. |
| Saudi Food and Drug Authority licensed establishments list, medical devices | 709 | 1 | 725 | Public register. |
| nupco (public register) | 243 | 1 | 251 | Public register. |
| Oman Ministry of Health approved medical device establishments | 107 | 1 | 107 | Public register. |
| Bahrain National Health Regulatory Authority medical device registration list | 38 | 1 | 38 | Public register. |
From registry rows to the Index
- Collect. Each registry is downloaded or read in full and cached, so a rerun never hits the source twice for the same page.
- 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.
- Merge. Rows become one establishment per company per country under the merge rule below.
- Classify. Roles come from the registry's own categories; segments come from the device listings linked to the establishment.
- Score. Each establishment gets a size score and a completeness score.
- 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.
The 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 and role classes
- Importer: Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence.
- Distributor: Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH).
- Wholesaler: Licensed as a wholesale dealer where the registry has that category.
- Authorised representative: Represents a foreign manufacturer towards the regulator (EU authorised representative and similar).
- Sponsor: Holds the market entry on behalf of a manufacturer, in markets that use that term.
- Registration holder: Holds device licences or registrations in its own name (Health Canada MDALL licence holder).
- Manufacturer: Registered as a manufacturer with an address in this market, including foreign registrations.
- Exporter: 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.
- Surgery and endoscopy (SURG, 7,587 establishments)
- Orthopaedics, spine and trauma (ORTH, 3,411 establishments)
- Cardiovascular (CARD, 3,199 establishments)
- Ear, nose and throat (ENT, 2,743 establishments)
- Gastroenterology, urology and OB/GYN (GIUR, 4,489 establishments)
- Dental (DENT, 4,077 establishments)
- Anaesthesia and respiratory (ANES, 3,096 establishments)
- Patient monitoring and neurology (MONI, 7,064 establishments)
- Ophthalmic (OPHT, 3,529 establishments)
- In-vitro diagnostics (IVD, 3,460 establishments)
- General hospital and consumables (CONS, 8,062 establishments)
- Aesthetics, dermatology and lasers (AEST, 570 establishments)
- Imaging, radiology and radiotherapy (RADI, 2,485 establishments)
27,907 establishments have no segment in their registry record. Imaging and radiology appear because the registries contain them.
Size score and completeness
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.
| Part | Weight | Full marks at |
|---|---|---|
| Products listed | 35 | 1,000 devices |
| Registrations held | 25 | 200 registrations |
| Registries it appears in | 15 | 5 sources |
| Principals represented | 15 | 50 manufacturers |
| Distinct roles | 10 | 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.
What search engines see
- 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.
How to cite
Cite the Index with its build date and the page you used:
Bastion Hale Distributor Index, 22 October 2026. https://bastionhale.com/distributors/
- Quote the build date shown on the page, because counts change with every monthly build.
- When you reuse the underlying records, credit the original registry as its licence requires (listed in the table above).
- Machine-readable summaries: /llms.txt and /llms-full.txt. Sample CSVs are linked from the distributors hub.
Corrections
If a profile describes your company and something is wrong or missing, use the "Claim this profile" button on it. Corrections that the registry confirms are applied in the next build.
Registry data. Bastion Hale does not vouch for any establishment.