Updated 23 October 2026
In-vitro diagnostics distributors in Spain: 32 licensed establishments
Spain has 3 independent distributors in the Index so far.
The Bastion Hale Distributor Index lists 32 establishments in Spain whose registry records include in-vitro diagnostics: 3 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 11 manufacturers' own import or sales entities, 1 regulatory representatives, and 17 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.
Listed
Independent distributors in the Index here, ranked by the lines each distributor carries, then registrations, then size.
- 1AKRALAB S.L.U.Alicante7 lines0 registrationssize 17.6
- 26 lines0 registrationssize 17.1
- 3ADACYTE THERAPEUTICS, S.L.Sant Cugat del Vallès1 line0 registrationssize 12.3
Include manufacturers, their own sales entities and regulatory representatives (29)
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.
- 1BIOGEN CIENTIFICA, S.L.MADRID12 lines0 registrationssize 19.5
- 2MEM HEI SHIN FARMA 72, S.L.PALMA DE MALLORCA4 lines0 registrationssize 18.1
- 3CERTEST BIOTEC S.L.SAN MATEO DE GALLEGO (ZARAGOZA)0 lines49 registrationssize 56.5
- 40 lines34 registrationssize 65.9
- 5Diagnostic Grifols, S.A.Parets de Valles, Barcelona0 lines16 registrationssize 54.0
- 6VITRO, S.A.SEVILLA0 lines8 registrationssize 38.6
- 7CYTOGNOS, S. L.Santa Marta de Tormes, Salamanca0 lines4 registrationssize 32.3
- 8iLine Microsystems, S.L.Donostia, Guipuzkoa0 lines3 registrationssize 31.3
- 9Roche Diagnostics, S.L.U.St. Cugat del Vallès0 lines1 registrationsize 22.1
- 100 lines0 registrationssize 9.7
- 11ASCENSIA DIABETES CARE SPAIN S.L.CORNELLÀ DE LLOBREGAT0 lines0 registrationssize 9.7
- 12Biokit S.A.LLIÇÀ D´AMUNT (BARCELONA)0 lines40 registrationssize 59.4
- 130 lines36 registrationssize 52.1
- 14Becton Dickinson, S.A.San Agustin del Guadalix0 lines11 registrationssize 49.0
- 15OPERON, S.A.Cuarte de Huerva - Zaragoza0 lines6 registrationssize 33.7
- 16HALOTECH DNA SLMadrid0 lines4 registrationssize 30.1
- 17IUL S.A.BARCELONA0 lines3 registrationssize 27.6
- 18CYDONIA PHARMA SLvalencia Valencia(Province)0 lines1 registrationsize 33.5
- 19Especialidades Médicas Myr S.L.ZARAGOZA0 lines1 registrationsize 28.6
- 20AQUISEL S.L.U.Abrera0 lines1 registrationsize 26.9
See Germany: 880 independent distributors
Distributor in Spain? Add your company, free
In-vitro diagnostics covers analysers, reagents, rapid tests and laboratory consumables across chemistry, haematology, microbiology, immunology and genetics. IVD has its own regulation in most markets, and the EU regulates it under IVDR rather than MDR. Laboratory distributors usually differ from device distributors, even inside the same company.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 15 | 47% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Authorised representative | 4 | 12% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 6 | 19% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 22 | 69% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 3 | 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 in-vitro diagnostics distributors in Spain
How many in-vitro diagnostics distributors are there in Spain?
The Index counts 32 establishments in Spain with in-vitro diagnostics in their registry record, of which 3 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 23 October 2026.
Who can hold an in-vitro diagnostics 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 in-vitro diagnostics 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 in-vitro diagnostics 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 in-vitro diagnostics 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
In-vitro diagnostics in other EU and EEA markets
Sources
- EUDAMED economic operator registration, European Commission public API: 24 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: 22 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 13 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): 9 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.