Updated 22 October 2026
Surgical and endoscopy device distributors in Poland: 30 licensed establishments
The Bastion Hale Distributor Index lists 30 establishments in Poland whose registry records include surgery and endoscopy: 10 with a channel role (importer, distributor, wholesaler or authorised representative), 0 registration holders without a channel role, and 20 registered as manufacturer or exporter only, out of 1,583 medical device establishments in Poland overall. The records come from US FDA (openFDA), EUDAMED, web and Health Canada, last seen on 23 October 2026.
General and plastic surgery covers instruments, electrosurgery, endoscopes, sutures and staplers. Most registries place surgical instruments in their largest category, so this segment usually has the most establishments and the widest spread of company sizes. Many of them are small instrument makers and importers rather than full-line distributors.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 8 | 27% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 2 | 7% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 2 | 7% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 1 | 3% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 26 | 87% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 2 | 7% | 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 20 surgery and endoscopy 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 | HTL-Strefa S.A. Ozorków | Channel Importer, Distributor, Registration holder, Manufacturer | General hospital and consumables, Surgery and endoscopy | 33 | 16 | 0 | 51.8 | 4/5 |
| 2 | Aesculap Chifa Sp. z o.o. Nowy Tomyśl | Channel Importer, Manufacturer | Cardiovascular, General hospital and consumables, Dental +5 more | 45 | 1 | 0 | 38.0 | 4/5 |
| 3 | Ascensia Diabetes Care Poland Sp. z o.o. Warsaw | Channel Importer, Manufacturer | In-vitro diagnostics, Patient monitoring and neurology, Surgery and endoscopy | 29 | 1 | 0 | 35.8 | 4/5 |
| 4 | SteriPack Medical Poland Sp. z o.o. Jelcz-Laskowice | Channel Authorised representative, Manufacturer | Cardiovascular, General hospital and consumables, Gastroenterology, urology and OB/GYN +3 more | 19 | 1 | 0 | 33.8 | 4/5 |
| 5 | MediVena Sp. z o.o. Warszawa | Channel Importer, Distributor, Manufacturer, Exporter | General hospital and consumables, In-vitro diagnostics, Surgery and endoscopy | 10 | 1 | 0 | 33.6 | 3/5 |
| 6 | LiNA Medical Polska Sp. z o.o. Sady | Channel Authorised representative, Manufacturer | Gastroenterology, urology and OB/GYN, Imaging, radiology and radiotherapy, Surgery and endoscopy | 17 | 1 | 0 | 33.2 | 4/5 |
| 7 | 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 |
| 8 | ALBIS MAZUR SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ KALISZ | Channel Importer | Aesthetics, dermatology and lasers, Cardiovascular, Gastroenterology, urology and OB/GYN +2 more | 0 | 0 | 6 | 20.5 | 4/5 |
| 9 | BELLA PHARMA SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ Gdańsk | Channel Importer | Aesthetics, dermatology and lasers, Surgery and endoscopy | 0 | 0 | 0 | 13.1 | 3/5 |
| 10 | 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 |
| 11 | 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 |
| 12 | 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 |
| 13 | 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 |
| 14 | AMETEK Poland sp. z o.o. Siechnice Dolnoslaskie | Manufacturer Manufacturer | Orthopaedics, spine and trauma, Surgery and endoscopy | 22 | 1 | 0 | 28.8 | 3/5 |
| 15 | 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 |
| 16 | Stryker Poland Manufacturing Sp. z o.o. Skawina Malopolskie | Manufacturer Manufacturer | Orthopaedics, spine and trauma, Surgery and endoscopy | 17 | 1 | 0 | 27.6 | 3/5 |
| 17 | BESTER MEDICAL SYSTEM SP. Z O. O. Nowa Deba Podkarpackie | Manufacturer Manufacturer | Orthopaedics, spine and trauma, Surgery and endoscopy | 10 | 1 | 0 | 25.1 | 3/5 |
| 18 | VERDENT LTD. LODZ Lodzkie | Manufacturer Manufacturer | Dental, Surgery and endoscopy | 8 | 1 | 0 | 24.1 | 3/5 |
| 19 | CLUNAS AG Tarnowo Podgorne Wielkopolskie | Manufacturer Manufacturer | Surgery and endoscopy | 6 | 1 | 0 | 22.8 | 3/5 |
| 20 | BERGER & KRAFT RASZYN Mazowieckie | Manufacturer Manufacturer | Surgery and endoscopy | 5 | 1 | 0 | 22.0 | 3/5 |
Questions about surgery and endoscopy distributors in Poland
How many surgery and endoscopy distributors are there in Poland?
The Index counts 30 establishments in Poland with surgery and endoscopy in their registry record, of which 10 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from US FDA (openFDA), EUDAMED, web and Health Canada and was last refreshed on 22 October 2026.
Who can hold a surgery and endoscopy 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 surgery and endoscopy 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 surgery and endoscopy 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 surgery and endoscopy 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
Surgery and endoscopy in other EU and EEA markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 26 establishments, last seen 22 October 2026. US government work, public domain.
- EUDAMED economic operator registration, European Commission public API: 11 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- web (public register): 4 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 1 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
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.