Updated 22 October 2026
Orthopaedic and spine device distributors in Spain: 25 licensed establishments
The Bastion Hale Distributor Index lists 25 establishments in Spain whose registry records include orthopaedics, spine and trauma: 8 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 6 manufacturers' own import or sales entities, 2 regulatory representatives, and 9 manufacturers or exporters, out of 1,874 medical device establishments in Spain overall. The records come from EUDAMED, US FDA (openFDA), MHRA UK and Health Canada, last seen on 23 October 2026.
Orthopaedics covers implants for joints, spine and trauma, together with instruments and bone substitutes. Implants are usually Class IIb or III, so the importer or registration holder carries real regulatory work and hospitals often buy through tenders. Distributors in this segment tend to employ clinical support staff who attend surgery.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 15 | 60% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 1 | 4% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 5 | 20% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 6 | 24% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 12 | 48% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 4 | 16% | 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 8 independent orthopaedics, spine and trauma distributors
Independent distributors only, ranked by the other manufacturers' lines they carry, then registrations held, then size.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | Valdent S.L. CASTELLÓN | Distributor Importer, Authorised representative | Dental, Ear, nose and throat, Orthopaedics, spine and trauma +1 more | 0 | 0 | 17 | 23.0 | 4/5 |
| 2 | ANCLADEN SL BARCELONA | Distributor Importer | Dental, Ear, nose and throat, Orthopaedics, spine and trauma +1 more | 0 | 0 | 3 | 15.0 | 4/5 |
| 3 | ASF GESTION, SL LEGANES | Distributor Importer | Aesthetics, dermatology and lasers, Ear, nose and throat, Patient monitoring and neurology +1 more | 0 | 0 | 2 | 13.9 | 4/5 |
| 4 | Klockner, S.L. Madrid | Distributor Importer, Authorised representative | General hospital and consumables, Dental, Patient monitoring and neurology +2 more | 0 | 0 | 1 | 14.6 | 4/5 |
| 5 | Advita Ortho Iberica SLU LLanera | Distributor Importer | General hospital and consumables, Orthopaedics, spine and trauma, Surgery and endoscopy | 0 | 0 | 1 | 12.3 | 4/5 |
| 6 | Biomedx Innovations, S.L.U Madrid | Distributor Importer | Patient monitoring and neurology, Orthopaedics, spine and trauma | 0 | 0 | 1 | 12.3 | 4/5 |
| 7 | ADEENE INVEST SLU Barcelona | Distributor Importer | Anaesthesia and respiratory, Orthopaedics, spine and trauma | 0 | 0 | 0 | 9.7 | 3/5 |
| 8 | BESTMEDIC ZARAGOZA | Distributor Importer | Patient monitoring and neurology, Orthopaedics, spine and trauma | 0 | 0 | 0 | 9.7 | 3/5 |
Include manufacturers, their own sales entities and regulatory representatives (17)
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.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. Miñano | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, General hospital and consumables +6 more | 192 | 34 | 0 | 65.9 | 3/5 |
| 2 | AVINENT IMPLANT SYSTEM, S.L.U. Santpedor, Barcelona | Maker's own entity Importer, Distributor, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, General hospital and consumables, Dental +1 more | 50 | 6 | 0 | 51.5 | 3/5 |
| 3 | AJL OPHTHALMIC, S.A. VITORIA GASTEIZ, Alava | Maker's own entity Importer, Authorised representative, Manufacturer | Anaesthesia and respiratory, Ophthalmic, Orthopaedics, spine and trauma | 5 | 6 | 0 | 37.6 | 3/5 |
| 4 | A2C SUMINISTROS HOSPITALARIOS, S.L MOLINS DE REI | Maker's own entity Importer | Orthopaedics, spine and trauma | 0 | 0 | 0 | 9.7 | 3/5 |
| 5 | Acumed Iberica Madrid | Maker's own entity Importer | Patient monitoring and neurology, Orthopaedics, spine and trauma, Surgery and endoscopy | 0 | 0 | 0 | 9.7 | 3/5 |
| 6 | AST Vision Care SL MADRID | Maker's own entity Importer | Ophthalmic, Orthopaedics, spine and trauma, Surgery and endoscopy | 0 | 0 | 0 | 9.7 | 3/5 |
| 7 | TERRATS MEDICAL, S.L. Barbera del Valles., Barcelona | Manufacturer Registration holder, Manufacturer | Dental, Orthopaedics, spine and trauma | 569 | 4 | 0 | 59.3 | 3/5 |
| 8 | IMPLANT PROTESIS DENTAL 2004, S.L. Premià de Dalt, Barcelona | Manufacturer Registration holder, Manufacturer, Exporter | Dental, Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy | 111 | 4 | 0 | 52.7 | 4/5 |
| 9 | CERAROOT S.L. Les Franqueses del Vallès | Manufacturer Registration holder, Manufacturer, Exporter | Dental, Orthopaedics, spine and trauma, Surgery and endoscopy | 8 | 3 | 0 | 37.0 | 4/5 |
| 10 | Neos Surgery, S.L. Cerdanyola del Valles, Barcelona | Manufacturer Registration holder, Manufacturer | Patient monitoring and neurology, Orthopaedics, spine and trauma | 4 | 3 | 0 | 34.3 | 4/5 |
| 11 | Aragogamma, S.L. Les Franqueses del Valles Barcelona | Manufacturer Manufacturer | Dental, Orthopaedics, spine and trauma | 48 | 1 | 0 | 32.7 | 3/5 |
| 12 | ABANZA TECNOMED, S.L. Mutilva | Manufacturer Manufacturer, Exporter | Orthopaedics, spine and trauma, Surgery and endoscopy | 13 | 1 | 0 | 32.0 | 4/5 |
| 13 | SAIMA GLOBAL FARMA S.L. GIRONA Gerona | Manufacturer Manufacturer | Aesthetics, dermatology and lasers, Gastroenterology, urology and OB/GYN, Orthopaedics, spine and trauma | 7 | 1 | 0 | 23.5 | 3/5 |
| 14 | AMES MEDICAL PROSTHETIC SOLUTIONS, S.A.U. SANT FELIU DEL LLOBREGAT (BARCELONA) | Manufacturer Manufacturer | Orthopaedics, spine and trauma | 1 | 1 | 0 | 22.3 | 4/5 |
| 15 | IONISOS Tarancon Cuenca | Manufacturer Manufacturer | Patient monitoring and neurology, Orthopaedics, spine and trauma | 5 | 1 | 0 | 22.0 | 3/5 |
| 16 | PRODUCTO SANITARIO INGENIERÍA Y CONSULTORÍA, S.L. MOSTOLES | Regulatory representative Importer, Authorised representative | Orthopaedics, spine and trauma | 0 | 0 | 0 | 11.9 | 3/5 |
| 17 | ASESORÍA DE CONSUMO Y SANIDAD S.L. Sotogrande | Regulatory representative Authorised representative | Anaesthesia and respiratory, General hospital and consumables, In-vitro diagnostics +2 more | 0 | 0 | 0 | 9.7 | 3/5 |
Questions about orthopaedics, spine and trauma distributors in Spain
How many orthopaedics, spine and trauma distributors are there in Spain?
The Index counts 25 establishments in Spain with orthopaedics, spine and trauma in their registry record, of which 8 are independent distributors (a channel role and no manufacturing of their own). The number comes from EUDAMED, US FDA (openFDA), MHRA UK and Health Canada and was last refreshed on 22 October 2026.
Who can hold a orthopaedics, spine and trauma 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 orthopaedics, spine and trauma 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 orthopaedics, spine and trauma 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 orthopaedics, spine and trauma 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
Orthopaedics, spine and trauma in other EU and EEA markets
Sources
- EUDAMED economic operator registration, European Commission public API: 22 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: 12 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 7 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 6 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- Company website (the establishment's own public site): 13 establishments, last seen 23 October 2026. Enrichment, not a registry: segments and principals read from the company's own website.
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.