Updated 22 October 2026
ENT device distributors in Poland: 10 licensed establishments
The Bastion Hale Distributor Index lists 10 establishments in Poland whose registry records include ear, nose and throat: 5 with a channel role (importer, distributor, wholesaler or authorised representative), 0 registration holders without a channel role, and 5 registered as manufacturer or exporter only, out of 1,583 medical device establishments in Poland overall. The records come from EUDAMED, US FDA (openFDA) and web, last seen on 23 October 2026.
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.
Top 10 ear, nose and throat establishments by size
Channel roles first, then registration holders, then manufacturers. Size is a 0 to 100 score; Complete is 0 to 5.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | "Medica 91" Spółka Jawna Anna Orywał-Barłowska, Marek Barłowski Poznań | Channel Importer | Aesthetics, dermatology and lasers, Ear, nose and throat, Patient monitoring and neurology | 0 | 0 | 14 | 23.4 | 4/5 |
| 2 | Comef Spółka z ograniczoną odpowiedzialnością Katowice | Channel Importer | Ear, nose and throat, In-vitro diagnostics, Patient monitoring and neurology +1 more | 0 | 0 | 8 | 21.4 | 4/5 |
| 3 | DRG MedTek Sp. z o.o. Warsaw | Channel Importer | Ear, nose and throat, Patient monitoring and neurology | 0 | 0 | 6 | 20.5 | 4/5 |
| 4 | Akson Padjasek-Krysowski Spółka Komandytowa Świętochłowice | Channel Importer | Ear, nose and throat, Gastroenterology, urology and OB/GYN, Patient monitoring and neurology +1 more | 0 | 0 | 3 | 18.4 | 4/5 |
| 5 | FISHER & PAYKEL HEALTHCARE POLAND SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ POZNAŃ | Channel Importer | Anaesthesia and respiratory, Ear, nose and throat, Patient monitoring and neurology +1 more | 0 | 0 | 0 | 13.1 | 3/5 |
| 6 | DGS Diagnostics Sp. z o.o Kolbaskowo Zachodniopomorskie | Manufacturer Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +3 more | 73 | 1 | 0 | 37.0 | 3/5 |
| 7 | Fabryka Narzędzi Medycznych Chirmed Marcin Dyner Spółka Komandytowa RUDNIKI | Manufacturer Manufacturer | Cardiovascular, General hospital and consumables, Dental +4 more | 44 | 1 | 0 | 35.6 | 4/5 |
| 8 | Demant Operations Poland Sp. z o.o. Mierzyn Zachodniopomorskie | Manufacturer Manufacturer | General hospital and consumables, Ear, nose and throat | 20 | 1 | 0 | 28.4 | 3/5 |
| 9 | FIDELTRONIK POLAND SP. Z O.O. Sucha Beskidzka Malopolskie | Manufacturer Manufacturer | Ear, nose and throat, Patient monitoring and neurology | 7 | 1 | 0 | 23.5 | 3/5 |
| 10 | Nordes Sp. z o.o. Wroclaw Dolnoslaskie | Manufacturer Manufacturer | Ear, nose and throat | 4 | 1 | 0 | 21.1 | 3/5 |
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 5 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from EUDAMED, US FDA (openFDA) and web and was last refreshed on 22 October 2026.
Who can hold a 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 a 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 reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a 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.
- web (public register): 5 establishments, last seen 23 October 2026. Public register.
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.