Who holds medical device registrations in the European Union

Who may hold a registration in the European Union

A manufacturer based outside the EU must designate a sole EU authorised representative before its device can be placed on the Union market, so one representative serves every member state. Every economic operator, meaning EU and non-EU manufacturers, authorised representatives, system or procedure pack producers and importers, must register as an actor in EUDAMED before placing devices on the EU market. Distributors are not on that list, so EUDAMED does not register them.

Sources: Regulation (EU) 2017/745 on medical devices (MDR), Article 11, European Commission, EUDAMED actor registration module.

EU authorised representatives in the European Union: top 50

EUDAMED publishes no count of mandates per representative, so the list is ordered as on the country pages: independent distributors first, then lines carried, registrations in other registries and size. Each name opens its profile with roles, principals and sources.

1. 1
   Woodys BCN SLVIC, Spain
   Distributor
2. 2
   Mikronmed ABKristianstad, Sweden
   Distributor
3. 3
   Dirame OrthoTernat, Belgium
   Distributor
4. 4
   Valdent S.L.Castellón, Spain
   Distributor
5. 5
   kipocoraPeaugres, France
   Distributor
6. 6
   OneMed Sverige ABHisings Kärra, Sweden
   Distributor
7. 7
   BIOMEDICAL SUPPLY, S.L.Valencia, Spain
   Distributor
8. 8
   Primacy Healthcare 21 LimitedBlarney, Ireland
   Distributor
9. 9
   GENERIQUE INTERNATIONALNoisy Le Grand, France
   Distributor
10. 10
    M. Bartels Reha Im- & Export GmbHSchenefeld, Germany
    Distributor
11. 11
    ELSE Solutions S.r.l.Trezzano sul Naviglio, Italy
    Distributor
12. 12
    M.T.V. MEDICAL S.R.L.Castiglione delle Stiviere, Italy
    Distributor
13. 13
    ALPATRIS srlPalermo (PA) Italy, Italy
    Distributor
14. 14
    Freyr Life Sciences GmbHLörrach, Germany
    Distributor
15. 15
    Addex Medical B.V.Helmond, Netherlands
    Distributor
16. 16
    CS Life Sciences Europe LtdDublin, Ireland
    Distributor
17. 17
    Klockner, S.L.Madrid, Spain
    Distributor
18. 18
    Go North Medical ABSävedalen, Sweden
    Distributor
19. 19
    Kaio-DiaLagraulet St Nicolas, France
    Distributor
20. 20
    Porta Medical UGHamburg, Germany
    Distributor
21. 21
    BIOMED SRLGenova, Italy
    Distributor
22. 22
    compliag GmbHWien, Austria
    Distributor
23. 23
    iHealthLabs Europe SASParis, France
    Distributor
24. 24
    Medovis Healthcare GmbHFrauental an der Lassnitz, Austria
    Distributor
25. 25
    Hopeway AMD B.V.Rotterdam, Netherlands
    Distributor
26. 26
    HARFINS GmbHWolfsburg, Germany
    Distributor
27. 27
    Supporting Health Care N.V.Ter Apel, Netherlands
    Distributor
28. 28
    Bernas MédicalParis, France
    Distributor
29. 29
    IVA Medical B.V.Terheijden, Netherlands
    Distributor
30. 30
    maxelbeautyNeerpelt, Belgium
    Distributor
31. 31
    Medical Workshop BVGroningen, Netherlands
    Distributor
32. 32
    Planète MédicaleColomiers, France
    Distributor
33. 33
    Schottlander (IRL) LimitedBray, Ireland
    Distributor
34. 34
    VITAIMED GmbHDüsseldorf, Germany
    Distributor
35. 35
    Biotango Spółka z ograniczoną odpowiedzialnościąKatowice, Poland
    Distributor
36. 36
    Josef Ruhri, Alpine Medical DevicesKatzelsdorf, Austria
    Distributor
37. 37
    LELOi ABStockholm, Sweden
    Distributor
38. 38
    Zug Medical SystemsBrignoles, France
    Distributor
39. 39
    BIO-TECHNE SASNoyal-Chatillon-Sur-Seiche, France
    Distributor
40. 40
    CoaChrom Diagnostica GmbHMaria Enzersdorf, Austria
    Distributor
41. 41
    Stemcup Medical Products GmbHLörrach, Germany
    Distributor
42. 42
    Vitafon PL Leonids BerkovičsWarszawa, Poland
    Distributor
43. 43
    Vlow Medical BVEindhoven, Netherlands
    Distributor
44. 44
    80 Beats Medical GmbHBerlin, Germany
    Distributor
45. 45
    Airwheel Europe S.A.Saint-Stevens-Woluwe, Belgium
    Distributor
46. 46
    ARV Supply Solutions B.V.Amsterdam, Netherlands
    Distributor
47. 47
    BioDomi GmbHHattersheim am Main, Germany
    Distributor
48. 48
    Cormalis ApSAgerskov, Denmark
    Distributor
49. 49
    Ellecom GmbHEfringen-Kirchen, Germany
    Distributor
50. 50
    FysioTape B.V.Enschede, Netherlands
    Distributor

Download all 2,490 company rows as CSV

Company level only: names that are only a person's name are left out.

How many holders also distribute

289 of the 2,490 holders listed here (12%) are also independent distributors in the Index: companies that supply the market for makers other than themselves, not a manufacturer, a maker's own entity or a regulatory service firm.

The others: 1,438 makers' own import or sales entities, 24 manufacturers and 739 regulatory representatives that hold registrations with no sign in the registries that they supply the market.

Holders that also distribute in the European Union: top 20

1. 1
   Woodys BCN SLVIC, Spain
   Distributor
2. 2
   Mikronmed ABKristianstad, Sweden
   Distributor
3. 3
   Dirame OrthoTernat, Belgium
   Distributor
4. 4
   Valdent S.L.Castellón, Spain
   Distributor
5. 5
   kipocoraPeaugres, France
   Distributor
6. 6
   OneMed Sverige ABHisings Kärra, Sweden
   Distributor
7. 7
   BIOMEDICAL SUPPLY, S.L.Valencia, Spain
   Distributor
8. 8
   Primacy Healthcare 21 LimitedBlarney, Ireland
   Distributor
9. 9
   GENERIQUE INTERNATIONALNoisy Le Grand, France
   Distributor
10. 10
    M. Bartels Reha Im- & Export GmbHSchenefeld, Germany
    Distributor
11. 11
    ELSE Solutions S.r.l.Trezzano sul Naviglio, Italy
    Distributor
12. 12
    M.T.V. MEDICAL S.R.L.Castiglione delle Stiviere, Italy
    Distributor
13. 13
    ALPATRIS srlPalermo (PA) Italy, Italy
    Distributor
14. 14
    Freyr Life Sciences GmbHLörrach, Germany
    Distributor
15. 15
    Addex Medical B.V.Helmond, Netherlands
    Distributor
16. 16
    CS Life Sciences Europe LtdDublin, Ireland
    Distributor
17. 17
    Klockner, S.L.Madrid, Spain
    Distributor
18. 18
    Go North Medical ABSävedalen, Sweden
    Distributor
19. 19
    Kaio-DiaLagraulet St Nicolas, France
    Distributor
20. 20
    Porta Medical UGHamburg, Germany
    Distributor

Independent holders in the European Union: top 20

Companies that hold registrations here with no sign in the registries that they supply the market themselves: regulatory representatives and holders as a service. A holder that is not your distributor keeps your distributors replaceable. Confirm what each one does before you appoint it.

1. 1
   EC Certification Service GmbHSankt Veit an der Glan, Austria
   Regulatory representative
2. 2
   OFHK EUROPE SRLTreviso, Italy
   Regulatory representative
3. 3
   CB Healthcare Consulting GmbHHamburg, Germany
   Regulatory representative
4. 4
   Kabomed GmbHVösendorf, Austria
   Regulatory representative
5. 5
   BIOTIKAAnnecy, France
   Regulatory representative
6. 6
   Agora Health ConsultingParis, France
   Regulatory representative
7. 7
   ACP Electromedicina, S.L.Dos Hermanas, Spain
   Regulatory representative
8. 8
   InterV Nordic ABSollentuna, Sweden
   Regulatory representative
9. 9
   AJW Technology Consulting GmbHDüsseldorf, Germany
   Regulatory representative
10. 10
    Cormedics Medizintechnik GmbHDeisenhofen, Germany
    Regulatory representative
11. 11
    MedEnvoy Global BVThe Hague, Netherlands
    Regulatory representative
12. 12
    PRODUCTO SANITARIO INGENIERÍA Y CONSULTORÍA, S.L.Mostoles, Spain
    Regulatory representative
13. 13
    ASESORÍA DE CONSUMO Y SANIDAD S.L.Sotogrande, Spain
    Regulatory representative
14. 14
    Holistic Business Excellence GmbHLangenwang, Austria
    Regulatory representative
15. 15
    Murrays Health and Beauty Europe LimitedDublin 2, Ireland
    Regulatory representative
16. 16
    Bo Edin ABLidingö, Sweden
    Regulatory representative
17. 17
    3DISC Dental Connect SASPuteaux, France
    Regulatory representative
18. 18
    beOriented S.r.l.Milano, Italy
    Regulatory representative
19. 19
    CWIRE Retail Holdings LtdDublin, Ireland
    Regulatory representative
20. 20
    EFTICOZonhoven, Belgium
    Regulatory representative

Authorised representatives and importers by country

EUDAMED lists authorised representatives and importers as registered actors. It does not register distributors, so the distributors on the country pages come from other registries.

Counts are companies in the Index that EUDAMED names as authorised representative or importer. EU medical device importers in 2026 looks at the importer side.

Medical device registration in the European Union with CE or FDA clearance

With CE marking: CE marking is the market authorisation itself.

With FDA clearance: No reliance route on FDA clearance is confirmed in the source.

CE marking under the MDR is the market authorisation; no national approval. A non-EU maker needs an EU authorised representative.

Sources: Regulation (EU) 2017/745 on medical devices (MDR), EUR-Lex. Confidence in this route: high, checked 23 October 2026. Rules change and differ by device class; confirm with the regulator before you plan a launch date.

How to check it yourself in the official register

EUDAMED, actor registration (economic operators). Search the economic operators by name, country or role. Authorised representatives and importers are there; distributors are not.

The register is the record that counts. Check the holder named on your own device's registration before you sign, and again before you change distributors.

What changes if you switch holder

The registration sits in the holder's name, not yours. If the holder is also your distributor, changing or adding a distributor means moving the registration or filing a new one, and where a regulator publishes a transfer process, the current holder has to take part.

Independent holders, firms that hold registrations for makers without selling their products, keep your distributors replaceable. In the Index, 739 of the companies listed here show no sign in the registries that they supply the market themselves, which is a place to start looking; confirm what each one does before you appoint it.

The article Who holds the registration compares holding it yourself, through an independent holder or through your distributor, and lists the clauses to agree before the first order.

Next step

All guides

Sources

• EUDAMED economic operator registration, European Commission public API: 2,490 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
• UK MHRA Public Access Registration Database (PARD): 256 establishments, last seen 23 October 2026. Public register.
• US FDA Establishment Registration and Device Listing, openFDA bulk download: 243 establishments, last seen 23 October 2026. US government work, public domain.
• Health Canada MDALL active licence listing and MDEL establishment licence listing: 89 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
• Company website (the establishment's own public site): 431 establishments, last seen 23 October 2026. Enrichment, not a registry: segments and principals read from the company's own website.

Index build 25 October 2026. Each establishment is counted once per country after resolving names across sources. Company records only, as the registries publish them.