Updated 22 October 2026
Surgical and endoscopy device distributors in Spain: 37 licensed establishments
The Bastion Hale Distributor Index lists 37 establishments in Spain whose registry records include surgery and endoscopy: 16 with a channel role (importer, distributor, wholesaler or authorised representative), 3 registration holders without a channel role, and 18 registered as manufacturer or exporter only, out of 1,855 medical device establishments in Spain overall. The records come from EUDAMED, US FDA (openFDA), web and Health Canada, last seen on 23 October 2026.
General and plastic surgery covers instruments, electrosurgery, endoscopes, sutures and staplers. Most registries place surgical instruments in their largest category, so this segment usually has the most establishments and the widest spread of company sizes. Many of them are small instrument makers and importers rather than full-line distributors.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 16 | 43% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 1 | 3% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 3 | 8% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 6 | 16% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 28 | 76% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 8 | 22% | 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.
Top 20 surgery and endoscopy establishments by size
Channel roles first, then registration holders, then manufacturers. Size is a 0 to 100 score; Complete is 0 to 5.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. Miñano | Channel Importer, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, General hospital and consumables +6 more | 192 | 28 | 0 | 63.1 | 3/5 |
| 2 | ZimVie Spain S.L.U. Cornellá de Llobregat (Barcelona) | Channel Importer, Authorised representative, Manufacturer | Dental, Surgery and endoscopy | 84 | 1 | 0 | 42.7 | 4/5 |
| 3 | INTERMEDIC ARFRAN, S.A. Madrid | Channel Importer, Registration holder, Manufacturer | Surgery and endoscopy | 8 | 4 | 0 | 38.1 | 3/5 |
| 4 | B. Braun Surgical, S.A. Rubi | Channel Importer, Manufacturer, Exporter | Cardiovascular, Surgery and endoscopy | 21 | 2 | 0 | 37.8 | 4/5 |
| 5 | OPTOMIC ESPANA, S.A. COLMENAR VIEJO - MADRID | Channel Importer, Manufacturer | Anaesthesia and respiratory, Ear, nose and throat, Gastroenterology, urology and OB/GYN +1 more | 11 | 1 | 0 | 31.2 | 4/5 |
| 6 | HERSILL, S.L. MOSTOLES | Channel Importer, Manufacturer | Anaesthesia and respiratory, General hospital and consumables, Surgery and endoscopy | 10 | 1 | 0 | 30.7 | 4/5 |
| 7 | INDIBA S.A.U. Sant Quirze del Vallés | Channel Importer, Manufacturer | Patient monitoring and neurology, Surgery and endoscopy | 6 | 1 | 0 | 28.5 | 4/5 |
| 8 | Telic, S.A.U. Bigues i Riells | Channel Importer, Registration holder, Manufacturer | Surgery and endoscopy | 1 | 2 | 0 | 28.0 | 4/5 |
| 9 | TOSKANI S.L Barcelona | Channel Importer, Distributor, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Patient monitoring and neurology, Surgery and endoscopy | 2 | 1 | 0 | 27.0 | 4/5 |
| 10 | Valdent S.L. CASTELLÓN | Channel Importer, Authorised representative | Dental, Ear, nose and throat, Orthopaedics, spine and trauma +1 more | 0 | 0 | 18 | 26.6 | 4/5 |
| 11 | ANCLADEN SL BARCELONA | Channel Importer | Dental, Ear, nose and throat, Orthopaedics, spine and trauma +1 more | 0 | 0 | 7 | 21.0 | 4/5 |
| 12 | Klockner, S.L. Madrid | Channel Importer, Authorised representative | General hospital and consumables, Dental, Patient monitoring and neurology +2 more | 0 | 0 | 3 | 20.6 | 4/5 |
| 13 | AGENOR MANTENIMIENTOS, SA TUDELA | Channel Importer | Surgery and endoscopy | 0 | 0 | 4 | 19.2 | 4/5 |
| 14 | Advita Ortho Iberica SLU LLanera | Channel Importer | General hospital and consumables, Orthopaedics, spine and trauma, Surgery and endoscopy | 0 | 0 | 2 | 17.3 | 4/5 |
| 15 | Acumed Iberica Madrid | Channel Importer | Patient monitoring and neurology, Orthopaedics, spine and trauma, Surgery and endoscopy | 0 | 0 | 0 | 13.1 | 3/5 |
| 16 | AST Vision Care SL MADRID | Channel Importer | Ophthalmic, Orthopaedics, spine and trauma, Surgery and endoscopy | 0 | 0 | 0 | 13.1 | 3/5 |
| 17 | CERAROOT S.L. Les Franqueses del Vallès | Holder Registration holder, Manufacturer, Exporter | Dental, Orthopaedics, spine and trauma, Surgery and endoscopy | 8 | 3 | 0 | 37.0 | 4/5 |
| 18 | CELSIUS MEDICAL, S.L. Ajalvir | Holder Registration holder, Manufacturer | Surgery and endoscopy | 14 | 1 | 0 | 32.3 | 4/5 |
| 19 | SWAN MEDICAL, S.L Barcelona | Holder Registration holder, Manufacturer | Surgery and endoscopy | 2 | 2 | 0 | 28.5 | 3/5 |
| 20 | CYDONIA PHARMA SL valencia Valencia(Province) | Manufacturer Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +4 more | 57 | 1 | 0 | 33.5 | 3/5 |
Questions about surgery and endoscopy distributors in Spain
How many surgery and endoscopy distributors are there in Spain?
The Index counts 37 establishments in Spain with surgery and endoscopy in their registry record, of which 16 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from EUDAMED, US FDA (openFDA), web and Health Canada and was last refreshed on 22 October 2026.
Who can hold a surgery and endoscopy 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 a surgery and endoscopy 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 reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a surgery and endoscopy 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 surgery and endoscopy 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
Surgery and endoscopy in other EU and EEA markets
Sources
- EUDAMED economic operator registration, European Commission public API: 29 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: 29 establishments, last seen 22 October 2026. US government work, public domain.
- web (public register): 7 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 6 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
Index build 22 October 2026. Each establishment is counted once per country after resolving names across sources. Named individuals are never collected.
Registry data. Bastion Hale does not vouch for any establishment.