Alpha-Bio Iberia
Málaga, Spain
Málaga-based official distributor of dental implantology, bone regeneration and digital dentistry solutions.
Bexen Medical
Hernani, Spain
Basque cooperative group manufacturing and distributing medical supplies and defibrillators since 1978.
Cimbis Orthodontics
Madrid, Spain
Madrid team specialised in distributing and advising on orthodontic and dental aesthetics products.
Distribuciones Especiales Dos
Madrid, Spain
Madrid distributor of medical equipment, exclusive for Spain and Portugal, with certified engineers.
Eckermann
Almoradí, Spain
Spanish manufacturer of dental implants based in Almoradí, Alicante, with over 25 years of experience.
Hans E. Rüth
Gavà, Spain
Barcelona-area distributor representing more than 20 medical technology manufacturers, founded in Madrid in 1928.
Hersill
Móstoles, Spain
Madrid manufacturer and distributor of medical and hospital equipment since 1973.
Imperortho
Alzira, Spain
Valencia-region dental depot specialising in orthodontic materials and official distributor of several brands.
Laboratorios Clarben
Alcobendas, Spain
Madrid-area laboratory manufacturing and distributing medicines and medical products for the dental sector.
Master Dental
Madrid, Spain
Madrid distributor of dental equipment and materials, serving clinics since 1984.
Microdent
Santa Eulàlia de Ronçana, Spain
Barcelona-area company specialising in the development and manufacture of dental implants.
RUMAR
Alpedrete, Spain
Madrid-area wholesaler importing and distributing dental spare parts, equipment and instruments since 2004.
Sanhigia
Zaragoza, Spain
Zaragoza distributor of oral surgery materials and dental products in Spain.
Suministros Médicos MEP
Ansoáin, Spain
Navarra distributor of medical-surgical supplies to public and private hospitals.
Business types in Spain
Cities in Spain
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Medical exhibitions 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.