Updated 22 October 2026
In-vitro diagnostics distributors in Finland: 22 licensed establishments
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.
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
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 17 | 77% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Authorised representative | 2 | 9% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 4 | 18% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 12 | 55% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 2 | 9% | 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.
Top 7 independent in-vitro diagnostics distributors
Independent distributors only, ranked by the other manufacturers' lines they carry, then registrations held, then size.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | Iogen Oy Tampere | Distributor Importer | Cardiovascular, General hospital and consumables, In-vitro diagnostics +4 more | 0 | 0 | 41 | 23.9 | 4/5 |
| 2 | BioNordika Oy Helsinki | Distributor Importer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +4 more | 0 | 0 | 8 | 18.1 | 4/5 |
| 3 | LABEMA OY Helsinki | Distributor Importer | In-vitro diagnostics | 0 | 0 | 8 | 18.1 | 4/5 |
| 4 | Tampereen Penli Oy Tampere | Distributor Importer | General hospital and consumables, Ear, nose and throat, Gastroenterology, urology and OB/GYN +1 more | 0 | 0 | 3 | 15.0 | 4/5 |
| 5 | Total Sec Oy Lahti | Distributor Importer | In-vitro diagnostics, Imaging, radiology and radiotherapy | 0 | 0 | 1 | 12.3 | 4/5 |
| 6 | Dual Laser Ltd. Oy Vantaa | Distributor Importer | In-vitro diagnostics, Ophthalmic | 0 | 0 | 0 | 9.7 | 3/5 |
| 7 | Medcase Finland Oy Espoo | Distributor Importer | In-vitro diagnostics | 0 | 0 | 0 | 9.7 | 3/5 |
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.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | Immuno Diagnostic Oy Hämeenlinna | Maker's own entity Importer | Anaesthesia and respiratory, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +1 more | 0 | 0 | 6 | 17.1 | 4/5 |
| 2 | Thermo Fisher Scientific Oy Vantaa, Uusimaa | Maker's own entity Importer, Authorised representative, Registration holder, Manufacturer | General hospital and consumables, In-vitro diagnostics, Patient monitoring and neurology +1 more | 90 | 12 | 2 | 61.6 | 5/5 |
| 3 | Serres Oy Kauhajoki, Länsi-Suomi | Maker's own entity Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +2 more | 12 | 4 | 2 | 46.0 | 5/5 |
| 4 | LINK Finland ESPOO | Maker's own entity Importer | In-vitro diagnostics, Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy +1 more | 0 | 0 | 1 | 12.3 | 4/5 |
| 5 | Wallac Oy Turku | Maker's own entity Importer, Authorised representative, Registration holder, Manufacturer, Exporter | Ear, nose and throat, In-vitro diagnostics | 73 | 47 | 0 | 63.5 | 4/5 |
| 6 | Biohit Oyj Helsinki | Maker's own entity Importer, Manufacturer | Gastroenterology, urology and OB/GYN, In-vitro diagnostics, Patient monitoring and neurology | 8 | 9 | 0 | 39.7 | 4/5 |
| 7 | Aidian Oy Espoo | Maker's own entity Importer, Manufacturer | Anaesthesia and respiratory, In-vitro diagnostics, Patient monitoring and neurology | 6 | 7 | 0 | 37.4 | 4/5 |
| 8 | Salofa Oy Salo | Maker's own entity Importer, Manufacturer | General hospital and consumables, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +1 more | 2 | 1 | 0 | 24.2 | 4/5 |
| 9 | Blueprint Genetics Oy Espoo | Maker's own entity Importer, Manufacturer | In-vitro diagnostics, Ophthalmic | 0 | 0 | 0 | 11.9 | 3/5 |
| 10 | Ascensia Diabetes Care Finland Oy Vantaa | Maker's own entity Importer | In-vitro diagnostics, Patient monitoring and neurology | 0 | 0 | 0 | 9.7 | 3/5 |
| 11 | LABSYSTEMS DIAGNOSTICS OY. Vantaa | Manufacturer Manufacturer | In-vitro diagnostics | 5 | 6 | 0 | 33.7 | 4/5 |
| 12 | Actim Oy Espoo | Manufacturer Registration holder, Manufacturer | In-vitro diagnostics | 2 | 3 | 0 | 29.8 | 4/5 |
| 13 | Sartorius Liquid Handling Oy Kajaani, Finland Kainuu | Manufacturer Manufacturer, Exporter | In-vitro diagnostics | 1 | 1 | 0 | 18.7 | 3/5 |
| 14 | Actim Oy Manufacturing Site Joensuu Pohjois-Karjala | Manufacturer Manufacturer | In-vitro diagnostics | 1 | 1 | 0 | 16.5 | 3/5 |
| 15 | HARALD AI OY Espoo Etela-Karjala | Manufacturer Manufacturer | In-vitro diagnostics | 1 | 1 | 0 | 16.5 | 3/5 |
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 22 October 2026.
Who can hold a 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 a 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 reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a 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
- EUDAMED economic operator registration, European Commission public API: 19 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 11 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 6 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 4 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- Company website (the establishment's own public site): 16 establishments, last seen 23 October 2026. Enrichment, not a registry: segments and principals read from the company's own website.
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.