Updated 23 October 2026

In-vitro diagnostics distributors in Finland: 22 licensed establishments

Finland has 7 independent distributors in the Index so far.

The Bastion Hale Distributor Index lists 22 establishments in Finland whose registry records include in-vitro diagnostics: 7 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 10 manufacturers' own import or sales entities, 0 regulatory representatives, and 5 manufacturers or exporters, out of 451 medical device establishments in Finland overall. The records come from EUDAMED, US FDA (openFDA), MHRA UK and Health Canada, last seen on 23 October 2026.

22establishments
7independent distributors
10makers' own sales entities
5manufacturers only

Listed

Independent distributors in the Index here, ranked by the lines each distributor carries, then registrations, then size.

  1. 1
    Iogen OyTampere
    41 lines0 registrationssize 23.9
  2. 2
    8 lines0 registrationssize 18.1
  3. 3
    LABEMA OYHelsinki
    8 lines0 registrationssize 18.1
  4. 4
    3 lines0 registrationssize 15.0
  5. 5
    1 line0 registrationssize 12.3
  6. 6
    0 lines0 registrationssize 9.7
  7. 7
    0 lines0 registrationssize 9.7
Include manufacturers, their own sales entities and regulatory representatives (15)

Manufacturers, companies that are a manufacturer's own import or sales arm, and regulatory representatives (authorised representatives, sponsors or registration holders with no import or distribution role). They are registered here but are not independent distributors.

  1. 1
    6 lines0 registrationssize 17.1
  2. 2
    2 lines12 registrationssize 61.6
  3. 3
    Serres OyKauhajoki, Länsi-Suomi
    2 lines4 registrationssize 46.0
  4. 4
    1 line0 registrationssize 12.3
  5. 5
    0 lines47 registrationssize 63.5
  6. 6
    Biohit OyjHelsinki
    0 lines9 registrationssize 39.7
  7. 7
    0 lines7 registrationssize 37.4
  8. 8
    0 lines1 registrationsize 24.2
  9. 9
    0 lines0 registrationssize 11.9
  10. 10
    0 lines0 registrationssize 9.7
  11. 11
    0 lines6 registrationssize 33.7
  12. 12
    0 lines3 registrationssize 29.8
  13. 13
    Sartorius Liquid Handling OyKajaani, Finland Kainuu
    0 lines1 registrationsize 18.7
  14. 14
    Actim Oy Manufacturing SiteJoensuu Pohjois-Karjala
    0 lines1 registrationsize 16.5
  15. 15
    HARALD AI OYEspoo Etela-Karjala
    0 lines1 registrationsize 16.5

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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

RoleEstablishmentsShareWhat it means
Importer1777%Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence.
Authorised representative29%Represents a foreign manufacturer towards the regulator (EU authorised representative and similar).
Registration holder418%Holds device licences or registrations in its own name (Health Canada MDALL licence holder).
Manufacturer1255%Registered as a manufacturer with an address in this market, including foreign registrations.
Exporter29%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 Finland

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.

This is the general rule, not legal advice. The registration clause in the first distributor contract decides who controls the market later. The Next 10 Markets report covers who holds the registration in each of your ten markets.

Questions about in-vitro diagnostics distributors in Finland

How many in-vitro diagnostics distributors are there in Finland?

The Index counts 22 establishments in Finland with in-vitro diagnostics in their registry record, of which 7 are independent distributors (a channel role and no manufacturing of their own). The number comes from EUDAMED, US FDA (openFDA), MHRA UK and Health Canada and was last refreshed on 23 October 2026.

Who can hold an in-vitro diagnostics device registration in Finland?

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 an in-vitro diagnostics distributor in Finland?

Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Finland to see the top three names. For a ranked shortlist for your device, see the Next 10 Markets report.

What does the Distributor Index count as an in-vitro diagnostics distributor in Finland?

A company that appears in a public regulatory registry with an address in Finland 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 Finland

In-vitro diagnostics in other EU and EEA markets

Sources

Index build 23 October 2026. Each establishment is counted once per country after resolving names across sources. Company records only, as the registries publish them.

Registry data. Bastion Hale does not vouch for any establishment.