Bexen Medical
Hernani, Spain
Basque cooperative group manufacturing and distributing medical supplies and defibrillators since 1978.
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Medical Instrument Companies in Spain
Bolsaplast Medical
Sabadell, Spain
Sabadell manufacturer of sterilisation pouches, reels and medical packaging.
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Distribuciones Especiales Dos
Madrid, Spain
Madrid distributor of medical equipment, exclusive for Spain and Portugal, with certified engineers.
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Hans E. Rüth
Gavà, Spain
Barcelona-area distributor representing more than 20 medical technology manufacturers, founded in Madrid in 1928.
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Henry Schein España
Madrid, Spain
Madrid-based Spanish operation of Henry Schein, offering dental depot and medical supply services for dental clinics, laboratories and medical professionals.
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Hersill
Móstoles, Spain
Madrid manufacturer and distributor of medical and hospital equipment since 1973.
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IHT – Iberhospitex
Lliçà de Vall, Spain
Catalan company developing, manufacturing and marketing medical devices.
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ORDISI
Pallejà, Spain
Barcelona-area manufacturer of electromedical equipment since 1959.
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PRIM
Madrid, Spain
Spanish healthcare company founded in 1870 that supplies hospital medical products and mobility and care products.
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RGB Medical Devices
Madrid, Spain
Madrid designer and manufacturer of multiparameter and neuromuscular transmission monitors, innovating since 1988.
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Suministros Médicos MEP
Ansoáin, Spain
Navarra distributor of medical-surgical supplies to public and private hospitals.
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Business types in Spain
Cities in Spain
Medical exhibitions in Spain
Verified specialties in Spain
Regulation in Spain
Spain is in the EU / EEA, so the EU framework applies.
Regulator: European Commission (DG SANTE) with national competent authorities of EU/EEA Member States
Two EU regulations govern medical devices and IVDs in the EU/EEA; devices need CE marking after the conformity assessment route set by their risk class.
From the sourced EU MDR / IVDR entry, checked 29 October 2026. General information, not legal advice. Requirements for Spain · All medical certifications
Frequently asked questions
What does a Spanish company take on when it acts as EU authorized representative?
A non-EU manufacturer must designate a single EU authorized representative by written mandate (Article 11 of the EU MDR), and an EU company, for example one in Spain, can take on that role. The authorized representative must:
- check that the Declaration of Conformity and technical documentation exist and keep copies available to authorities;
- register in EUDAMED and cooperate on corrective actions and incidents;
- have a PRRC available;
- end the mandate and inform the authority if the manufacturer breaches its obligations.
The authorized representative's details appear on the labeling. It is not automatically the importer or distributor. Browse Spanish companies on the Spain country page.