Updated 22 October 2026
In-vitro diagnostics distributors in Spain: 31 licensed establishments
The Bastion Hale Distributor Index lists 31 establishments in Spain whose registry records include in-vitro diagnostics: 15 with a channel role (importer, distributor, wholesaler or authorised representative), 3 registration holders without a channel role, and 13 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.
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 | 14 | 45% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Authorised representative | 3 | 10% | 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 | 71% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 3 | 10% | 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 in-vitro diagnostics 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 | Diagnostic Grifols, S.A. Parets de Valles | Channel Importer, Authorised representative, Registration holder, Manufacturer | In-vitro diagnostics | 35 | 7 | 0 | 48.5 | 3/5 |
| 3 | CERTEST BIOTEC S.L. SAN MATEO DE GALLEGO (ZARAGOZA) | Channel Importer, Registration holder, Manufacturer | In-vitro diagnostics | 28 | 10 | 0 | 45.3 | 4/5 |
| 4 | VITRO, S.A. SEVILLA | Channel Importer, Manufacturer | In-vitro diagnostics | 4 | 1 | 0 | 26.7 | 4/5 |
| 5 | ILINE MICROSYSTEMS S.L. Donostia | Channel Importer, Manufacturer | In-vitro diagnostics | 3 | 1 | 0 | 25.6 | 3/5 |
| 6 | BIOGEN CIENTIFICA, S.L. MADRID | Channel Importer | General hospital and consumables, In-vitro diagnostics, Imaging, radiology and radiotherapy | 0 | 0 | 12 | 22.9 | 4/5 |
| 7 | CYTOGNOS, S.L. Santa Marta de Tormes | Channel Importer, Manufacturer | In-vitro diagnostics | 1 | 1 | 0 | 22.1 | 4/5 |
| 8 | Roche Diagnostics, S.L.U. St. Cugat del Vallès | Channel Importer, Manufacturer | In-vitro diagnostics | 1 | 1 | 0 | 22.1 | 3/5 |
| 9 | MEM HEI SHIN FARMA 72, S.L. PALMA DE MALLORCA | Channel Importer, Authorised representative | Anaesthesia and respiratory, General hospital and consumables, In-vitro diagnostics +1 more | 0 | 0 | 4 | 21.5 | 4/5 |
| 10 | AKRALAB S.L.U. Alicante | Channel Importer | Anaesthesia and respiratory, Ear, nose and throat, In-vitro diagnostics | 0 | 0 | 8 | 21.4 | 4/5 |
| 11 | AIRMEDICAL PRODUCTS, S.L. MADRID | Channel Importer | Anaesthesia and respiratory, In-vitro diagnostics, Patient monitoring and neurology | 0 | 0 | 7 | 21.0 | 4/5 |
| 12 | ADACYTE THERAPEUTICS, S.L. Sant Cugat del Vallès | Channel Importer | Cardiovascular, Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 0 | 0 | 1 | 15.7 | 4/5 |
| 13 | ASCENSIA DIABETES CARE SPAIN S.L. CORNELLÀ DE LLOBREGAT | Channel Importer | In-vitro diagnostics, Patient monitoring and neurology | 0 | 0 | 1 | 15.7 | 4/5 |
| 14 | AP MEDICAL SUMINISTROS MÉDICOS AUXILIARES, S.L. Rubí | Channel Importer | In-vitro diagnostics | 0 | 0 | 0 | 13.1 | 3/5 |
| 15 | ASESORÍA DE CONSUMO Y SANIDAD S.L. Sotogrande | Channel Authorised representative | Anaesthesia and respiratory, General hospital and consumables, In-vitro diagnostics +2 more | 0 | 0 | 0 | 13.1 | 3/5 |
| 16 | Biokit S.A. LLIÇÀ D´AMUNT (BARCELONA) | Holder Registration holder, Manufacturer, Exporter | In-vitro diagnostics | 58 | 29 | 0 | 56.0 | 3/5 |
| 17 | Progenika Biopharma, S.A. Derio | Holder Registration holder, Manufacturer | In-vitro diagnostics | 15 | 16 | 0 | 45.1 | 3/5 |
| 18 | Becton Dickinson, S.A. San Agustin del Guadalix | Holder Registration holder, Manufacturer | Anaesthesia and respiratory, General hospital and consumables, In-vitro diagnostics | 32 | 3 | 0 | 42.0 | 3/5 |
| 19 | 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 |
| 20 | AQUISEL S.L.U. Abrera | Manufacturer Manufacturer | In-vitro diagnostics | 7 | 1 | 0 | 26.9 | 3/5 |
Questions about in-vitro diagnostics distributors in Spain
How many in-vitro diagnostics distributors are there in Spain?
The Index counts 31 establishments in Spain with in-vitro diagnostics in their registry record, of which 15 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 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 a 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 reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a 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: 23 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 22 October 2026. US government work, public domain.
- web (public register): 8 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.