Updated 22 October 2026
Gastroenterology and urology device distributors in Spain: 19 licensed establishments
The Bastion Hale Distributor Index lists 19 establishments in Spain whose registry records include gastroenterology, urology and ob/gyn: 8 with a channel role (importer, distributor, wholesaler or authorised representative), 1 registration holders without a channel role, and 10 registered as manufacturer or exporter only, out of 1,855 medical device establishments in Spain overall. The records come from US FDA (openFDA), EUDAMED, Health Canada and web, last seen on 23 October 2026.
Gastroenterology, urology and obstetrics covers flexible endoscopy accessories, lithotripsy, dialysis, catheters and women's health devices. Dialysis consumables bring large recurring volumes and a few dominant players. The rest of the segment is spread across many mid-sized importers.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 7 | 37% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 1 | 5% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 1 | 5% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 2 | 11% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 15 | 79% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 5 | 26% | 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 19 gastroenterology, urology and ob/gyn 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 | Orliman, S.L.U. La Pobla de Vallbona (Valencia) | Channel Importer, Authorised representative, Manufacturer | General hospital and consumables, Gastroenterology, urology and OB/GYN, Patient monitoring and neurology | 27 | 1 | 0 | 37.1 | 4/5 |
| 3 | Improving Mobility Development SL Madrid | Channel Importer, Manufacturer | General hospital and consumables, Gastroenterology, urology and OB/GYN, Patient monitoring and neurology | 18 | 1 | 0 | 33.5 | 4/5 |
| 4 | 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 |
| 5 | DRYLOCK TECHNOLOGIES SL. Hontoria Segovia | Channel Distributor, Manufacturer | Gastroenterology, urology and OB/GYN | 3 | 1 | 0 | 22.2 | 3/5 |
| 6 | Laboratorios Indas, S.A.U. Madrid | Channel Importer, Manufacturer | Gastroenterology, urology and OB/GYN | 1 | 1 | 0 | 22.1 | 4/5 |
| 7 | Bionet Medical S.L. MADRID | Channel Importer | Cardiovascular, Gastroenterology, urology and OB/GYN, Patient monitoring and neurology | 0 | 0 | 3 | 18.4 | 4/5 |
| 8 | 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 |
| 9 | COTTON HIGH TECH, S.L. Balsareny Barcelona | Holder Registration holder, Manufacturer | Gastroenterology, urology and OB/GYN | 11 | 6 | 0 | 37.1 | 3/5 |
| 10 | 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 |
| 11 | DESARROLLO E INVESTIGACION MEDICA ARAGONESA S.L. Calatayud | Manufacturer Manufacturer | Gastroenterology, urology and OB/GYN, Surgery and endoscopy | 6 | 1 | 0 | 26.2 | 4/5 |
| 12 | Meiji Pharma Spain, S.A. Alcalá de Henares (Madrid) | Manufacturer Manufacturer, Exporter | Gastroenterology, urology and OB/GYN | 2 | 1 | 0 | 24.2 | 4/5 |
| 13 | NEW WELLNESS CONCEPT SL Sevilla | Manufacturer Manufacturer, Exporter | Gastroenterology, urology and OB/GYN | 2 | 1 | 0 | 24.2 | 3/5 |
| 14 | NEOMEDIC INTERNATIONAL TERRASA Barcelona | Manufacturer Exporter | Gastroenterology, urology and OB/GYN, Surgery and endoscopy | 7 | 1 | 0 | 23.5 | 3/5 |
| 15 | 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 |
| 16 | TRANSCENDENCIAS COMERCIALES, S.L. ASTIGARRAGA | Manufacturer Manufacturer | Gastroenterology, urology and OB/GYN | 1 | 1 | 0 | 19.8 | 4/5 |
| 17 | ECAREYOU INNOVATION S.L. Madrid | Manufacturer Manufacturer | Gastroenterology, urology and OB/GYN | 1 | 1 | 0 | 19.8 | 3/5 |
| 18 | ONTEX PENINSULAR SAU SEGOVIA | Manufacturer Manufacturer | Gastroenterology, urology and OB/GYN | 2 | 1 | 0 | 18.5 | 3/5 |
| 19 | Paul Hartmann Iberia S.A. Montornes del Valles Barcelona | Manufacturer Manufacturer | Gastroenterology, urology and OB/GYN | 1 | 1 | 0 | 16.5 | 3/5 |
Questions about gastroenterology, urology and ob/gyn distributors in Spain
How many gastroenterology, urology and ob/gyn distributors are there in Spain?
The Index counts 19 establishments in Spain with gastroenterology, urology and ob/gyn in their registry record, of which 8 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from US FDA (openFDA), EUDAMED, Health Canada and web and was last refreshed on 22 October 2026.
Who can hold a gastroenterology, urology and ob/gyn 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 gastroenterology, urology and ob/gyn 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 gastroenterology, urology and ob/gyn 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 gastroenterology, urology and ob/gyn 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
Gastroenterology, urology and OB/GYN in other EU and EEA markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 17 establishments, last seen 22 October 2026. US government work, public domain.
- EUDAMED economic operator registration, European Commission public API: 12 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 2 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
- web (public register): 2 establishments, last seen 23 October 2026. Public register.
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.