Updated 23 October 2026
ENT device distributors in Poland: 10 licensed establishments
Poland has 3 independent distributors in the Index so far.
The Bastion Hale Distributor Index lists 10 establishments in Poland whose registry records include ear, nose and throat: 3 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 5 manufacturers or exporters, out of 1,618 medical device establishments in Poland overall. The records come from EUDAMED and US FDA (openFDA), last seen on 23 October 2026.
Listed
Independent distributors in the Index here, ranked by the lines each distributor carries, then registrations, then size.
- 110 lines0 registrationssize 18.8
- 25 lines0 registrationssize 16.5
- 3Akson Padjasek-Krysowski Spółka KomandytowaŚwiętochłowice3 lines0 registrationssize 15.0
Include manufacturers, their own sales entities and regulatory representatives (7)
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.
- 1DRG MedTek Sp. z o.o.Warsaw1 line0 registrationssize 12.3
- 20 lines0 registrationssize 9.7
- 3DGS Diagnostics Sp. z o.oKolbaskowo Zachodniopomorskie0 lines1 registrationsize 37.0
- 40 lines1 registrationsize 35.6
- 5Demant Operations Poland Sp. z o.o.Mierzyn Zachodniopomorskie0 lines1 registrationsize 28.4
- 6FIDELTRONIK POLAND SP. Z O.O.Sucha Beskidzka Malopolskie0 lines1 registrationsize 23.5
- 7Nordes Sp. z o.o.Wroclaw Dolnoslaskie0 lines1 registrationsize 21.1
See Germany: 880 independent distributors
Distributor in Poland? Add your company, free
Ear, nose and throat covers hearing devices, cochlear implants, sinus and laryngology instruments, and audiology equipment. Hearing aids often go through retail audiology chains rather than hospital distributors, so the establishment list mixes both. Volumes per establishment are smaller than in surgery.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 5 | 50% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Manufacturer | 5 | 50% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 1 | 10% | 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.
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 ear, nose and throat distributors in Poland
How many ear, nose and throat distributors are there in Poland?
The Index counts 10 establishments in Poland with ear, nose and throat in their registry record, of which 3 are independent distributors (a channel role and no manufacturing of their own). The number comes from EUDAMED and US FDA (openFDA) and was last refreshed on 23 October 2026.
Who can hold an ear, nose and throat 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 an ear, nose and throat 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 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 ear, nose and throat 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 ear, nose and throat 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
Ear, nose and throat in other EU and EEA markets
Sources
- EUDAMED economic operator registration, European Commission public API: 6 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: 5 establishments, last seen 22 October 2026. US government work, public domain.
- 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 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.