Updated 23 October 2026
ENT device distributors in Spain: 11 licensed establishments
Spain has 5 independent distributors in the Index so far.
The Bastion Hale Distributor Index lists 11 establishments in Spain whose registry records include ear, nose and throat: 5 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 2 manufacturers' own import or sales entities, 0 regulatory representatives, and 4 manufacturers or exporters, out of 1,874 medical device establishments in Spain overall. The records come from EUDAMED, US FDA (openFDA) and MHRA UK, last seen on 23 October 2026.
Listed
Independent distributors in the Index here, ranked by the lines each distributor carries, then registrations, then size.
- 1Valdent S.L.CASTELLÓN17 lines0 registrationssize 23.0
- 2AKRALAB S.L.U.Alicante7 lines0 registrationssize 17.6
- 3ANCLADEN SLBARCELONA3 lines0 registrationssize 15.0
- 4ASF GESTION, SLLEGANES2 lines0 registrationssize 13.9
- 50 lines0 registrationssize 9.7
Include manufacturers, their own sales entities and regulatory representatives (6)
Manufacturers, companies that are a manufacturer's own import or sales arm, and regulatory representatives (authorised representatives, sponsors or registration holders with no import or distribution role). They are registered here but are not independent distributors.
- 1OPTOMIC ESPANA, S.A.COLMENAR VIEJO - MADRID, MADRID0 lines1 registrationsize 33.6
- 2UNION DENTAL S.A.Tielmes0 lines1 registrationsize 26.7
- 3CYDONIA PHARMA SLvalencia Valencia(Province)0 lines1 registrationsize 33.5
- 4LABORATORIES QUINTON INTERNATIONAL S. L.Valencia Alicante0 lines1 registrationsize 16.5
- 5INSDINIA S.L.Barcelona0 lines0 registrationssize 11.9
- 6Yousfis S.L.Leganés (Madrid)0 lines0 registrationssize 11.9
See Germany: 880 independent distributors
Distributor in Spain? Add your company, free
Ear, nose and throat covers hearing devices, cochlear implants, sinus and laryngology instruments, and audiology equipment. Hearing aids often go through retail audiology chains rather than hospital distributors, so the establishment list mixes both. Volumes per establishment are smaller than in surgery.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 9 | 82% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Authorised representative | 3 | 27% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Manufacturer | 3 | 27% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 1 | 9% | Registered with the US FDA as an exporter of devices made for export. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in Spain
In the EU and EEA the manufacturer, or its EU authorised representative for manufacturers based outside the EU, registers in EUDAMED and holds the CE marking file. Importers and distributors register separately as economic operators and never own the registration, which is why EU channel changes are easier than elsewhere.
This is the general rule, not legal advice. The registration clause in the first distributor contract decides who controls the market later. The Next 10 Markets report covers who holds the registration in each of your ten markets.
Questions about ear, nose and throat distributors in Spain
How many ear, nose and throat distributors are there in Spain?
The Index counts 11 establishments in Spain with ear, nose and throat in their registry record, of which 5 are independent distributors (a channel role and no manufacturing of their own). The number comes from EUDAMED, US FDA (openFDA) and MHRA UK and was last refreshed on 23 October 2026.
Who can hold an ear, nose and throat device registration in Spain?
In the EU and EEA the manufacturer, or its EU authorised representative for manufacturers based outside the EU, registers in EUDAMED and holds the CE marking file. Importers and distributors register separately as economic operators and never own the registration, which is why EU channel changes are easier than elsewhere.
How do I find an ear, nose and throat distributor in Spain?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Spain to see the top three names. For a ranked shortlist for your device, see the Next 10 Markets report.
What does the Distributor Index count as an ear, nose and throat distributor in Spain?
A company that appears in a public regulatory registry with an address in Spain and whose linked device listings fall in the ear, nose and throat segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
Other segments in Spain
Ear, nose and throat in other EU and EEA markets
Sources
- EUDAMED economic operator registration, European Commission public API: 9 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 4 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 1 establishments, last seen 23 October 2026. Public register.
- Company website (the establishment's own public site): 7 establishments, last seen 23 October 2026. Enrichment, not a registry: segments and principals read from the company's own website.
Index build 23 October 2026. Each establishment is counted once per country after resolving names across sources. Company records only, as the registries publish them.
Registry data. Bastion Hale does not vouch for any establishment.