Updated 22 October 2026
In-vitro diagnostics distributors in Poland: 14 licensed establishments
The Bastion Hale Distributor Index lists 14 establishments in Poland whose registry records include in-vitro diagnostics: 5 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 2 manufacturers' own import or sales entities, 0 regulatory representatives, and 7 manufacturers or exporters, out of 1,618 medical device establishments in Poland overall. The records come from US FDA (openFDA), EUDAMED and MHRA UK, 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 | 7 | 50% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 1 | 7% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 1 | 7% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Manufacturer | 9 | 64% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 2 | 14% | 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 Poland
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 5 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 | Argenta Spółka z ograniczoną odpowiedzialnością Poznań | Distributor Importer | In-vitro diagnostics, Patient monitoring and neurology | 0 | 0 | 9 | 18.5 | 4/5 |
| 2 | Comef Spółka z ograniczoną odpowiedzialnością Katowice | Distributor Importer | Ear, nose and throat, In-vitro diagnostics, Patient monitoring and neurology +1 more | 0 | 0 | 5 | 16.5 | 4/5 |
| 3 | Biotango Spółka z ograniczoną odpowiedzialnością KATOWICE | Distributor Importer, Authorised representative | Cardiovascular, In-vitro diagnostics, Patient monitoring and neurology | 0 | 0 | 0 | 11.9 | 3/5 |
| 4 | Axon Lab Sp. z o.o. Warsaw | Distributor Importer | In-vitro diagnostics | 0 | 0 | 0 | 9.7 | 3/5 |
| 5 | BIOGENET SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ Józefów | Distributor Importer | Anaesthesia and respiratory, In-vitro diagnostics, Patient monitoring and neurology +1 more | 0 | 0 | 0 | 9.7 | 3/5 |
Include manufacturers, their own sales entities and regulatory representatives (9)
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 | Ascensia Diabetes Care Poland Sp. z o.o. Warsaw | Maker's own entity Importer, Manufacturer | In-vitro diagnostics, Patient monitoring and neurology, Surgery and endoscopy | 29 | 1 | 0 | 35.8 | 4/5 |
| 2 | MediVena Sp. z o.o. Warszawa | Maker's own entity Importer, Distributor, Manufacturer, Exporter | General hospital and consumables, In-vitro diagnostics, Surgery and endoscopy | 10 | 1 | 0 | 33.6 | 3/5 |
| 3 | Avantor Performance Materials Poland S.A. Gliwice | Manufacturer Manufacturer | In-vitro diagnostics | 5 | 2 | 0 | 29.7 | 4/5 |
| 4 | STERISERVICE SP. Z O.O. Czestochowa Slaskie | Manufacturer Manufacturer | Anaesthesia and respiratory, General hospital and consumables, Gastroenterology, urology and OB/GYN +3 more | 30 | 1 | 0 | 30.3 | 3/5 |
| 5 | Radiometer Solutions Sp. z o.o. Stargard Zachodniopomorskie | Manufacturer Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +1 more | 22 | 1 | 0 | 28.8 | 3/5 |
| 6 | Clinico Medical Sp. z o.o. Blonie/Miekinia Dolnoslaskie | Manufacturer Manufacturer | Anaesthesia and respiratory, General hospital and consumables, Gastroenterology, urology and OB/GYN +2 more | 19 | 1 | 0 | 28.1 | 3/5 |
| 7 | Radiometer Sp. z o.o Stargard Zachodniopomorskie | Manufacturer Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +1 more | 15 | 1 | 0 | 27.0 | 3/5 |
| 8 | RR Donnelley GTS Poland Sp. z o.o. Lodz Lodzkie | Manufacturer Manufacturer, Exporter | In-vitro diagnostics, Patient monitoring and neurology | 9 | 1 | 0 | 26.9 | 3/5 |
| 9 | Kimball Electronics Poland Sp.z o.o Tarnowo Podgorne Wielkopolskie | Manufacturer Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +3 more | 14 | 1 | 0 | 26.7 | 3/5 |
Questions about in-vitro diagnostics distributors in Poland
How many in-vitro diagnostics distributors are there in Poland?
The Index counts 14 establishments in Poland with in-vitro diagnostics in their registry record, of which 5 are independent distributors (a channel role and no manufacturing of their own). The number comes from US FDA (openFDA), EUDAMED and MHRA UK and was last refreshed on 22 October 2026.
Who can hold a in-vitro diagnostics device registration in Poland?
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 Poland?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Poland 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 Poland?
A company that appears in a public regulatory registry with an address in Poland 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 Poland
In-vitro diagnostics in other EU and EEA markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 9 establishments, last seen 23 October 2026. US government work, public domain.
- EUDAMED economic operator registration, European Commission public API: 8 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- UK MHRA Public Access Registration Database (PARD): 1 establishments, last seen 23 October 2026. Public register.
- Company website (the establishment's own public site): 5 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.