Updated 23 October 2026
Surgical and endoscopy device distributors in Poland: 32 licensed establishments
EUDAMED does not list distributors, so the Index only sees the 3 independent distributors tagged surgery and endoscopy that appear as importers or in other registries. The real number is higher.
The Bastion Hale Distributor Index lists 32 establishments in Poland whose registry records include surgery and endoscopy: 3 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 8 manufacturers' own import or sales entities, 0 regulatory representatives, and 21 manufacturers or exporters, out of 1,618 medical device establishments in Poland overall. The records come from US FDA (openFDA), EUDAMED, MHRA UK and Health Canada, last seen on 23 October 2026.
Entry decision: surgery and endoscopy (SURG) in Poland
For a typical maker, from public data and the free Market Finder. Your own clearance, device class and current markets change the answer.
CE marked, shipping from the EU
Go now Rank 13 of 112 markets for this maker.
Your CE marking is the market authorisation; foreign makers sell through distributors here; health spending of USD 73.6bn (2024, World Bank); distributor numbers not countable here because EUDAMED does not list distributors (3 seen in SURG so far).
Medium confidence: EUDAMED does not list distributors, so the count seen in SURG (3) is a minimum.
FDA cleared, shipping from the US
Build the case Rank 20 of 112 markets for this maker.
Held back: CE marking needed first; FDA clearance alone is not accepted here.
Medium confidence: EUDAMED does not list distributors, so the count seen in SURG (3) is a minimum.
Registration route
With CE marking: Your CE marking is the market authorisation. High confidence.
With FDA clearance: CE marking needed first; FDA clearance alone is not accepted here. High confidence.
No local holder is needed for a maker based inside this regulatory area. Who holds the registration
CE marking under the MDR is the market authorisation; no national approval. A non-EU maker needs an EU authorised representative.
Timeline and fees are not shown: no official source we cite gives them for this market yet. Confirm with a regulatory specialist before you plan a launch date. Sources: Regulation (EU) 2017/745 on medical devices (MDR), EUR-Lex.
Sales channel
Distributor-led: Foreign makers sell through distributors here. Polish trade partners most often serve foreign manufacturers as distributors; many are technically specialised.
US Commercial Service country guide, published 3 April 2026.
Independent distributors in the Index: 3 for surgery and endoscopy, 484 in Poland overall.
Makers registered here: 8 makers' own import or sales entities and 21 manufacturers.
Landed cost
Landed cost from the EU: no duty or import tax collected at the border (same customs area).
Landed cost from the US: about 23% collected at the border, under 1% real after credits (high confidence, from published tariff and tax rates). No duty, import VAT or GST about 23%.
Tariff basket: surgery and endoscopy. Cash is collected at clearance. Real cost is what stays after a registered distributor recovers VAT and charges. Sources: World Bank WITS TRAINS tariff API, reporter 918, MFN applied, HS6, Your Europe: VAT rates applied in EU member countries (last checked 13/07/2026).
Market size
Health spending: USD 73.6bn in 2024, USD 2,014 per person (World Bank).
Surgery and endoscopy (TAM): about USD 530m to 870m a year (estimate, low confidence).
For one product line sold through distributors: SAM about USD 39m to 130m, SOM about USD 570k to 3.5m a year (estimate). The free Market Finder sizes your own product range.
Broad scope, as in MedTech Europe figures: devices, diagnostics and consumables at manufacturer prices. Narrower published figures are lower.
How we estimate. At manufacturer prices.
Next step
The finder ranks every market for your own device, clearance and current markets. The CSV lists 1,577 establishments, the 464 independent distributors first. Company records only. 41 rows are not in the CSV and stay on their profile pages, for example names of a person or records whose only source is the Health Canada licence list.
Listed
Independent distributors in the Index here, ranked by the lines each distributor carries, then registrations, then size.
- 111 lines0 registrationssize 21.4
- 26 lines0 registrationssize 17.1
- 35 lines0 registrationssize 16.5
Include manufacturers, their own sales entities and regulatory representatives (29)
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.
- 1HTL-Strefa S.A.Ozorków0 lines16 registrationssize 53.7
- 2SteriPack Medical Poland Sp. z o.o.Jelcz-Laskowice0 lines1 registrationsize 36.2
- 3Aesculap Chifa Sp. z o.o.Nowy Tomyśl0 lines1 registrationsize 38.0
- 40 lines1 registrationsize 35.8
- 5MediVena Sp. z o.o.Warszawa0 lines1 registrationsize 33.6
- 60 lines1 registrationsize 33.2
- 70 lines0 registrationssize 9.7
- 80 lines0 registrationssize 9.7
- 90 lines1 registrationsize 35.6
- 10DGS Diagnostics Sp. z o.oKolbaskowo Zachodniopomorskie0 lines1 registrationsize 37.0
- 11STERISERVICE SP. Z O.O.Czestochowa Slaskie0 lines1 registrationsize 30.3
- 12AMETEK Poland sp. z o.o.Siechnice Dolnoslaskie0 lines1 registrationsize 28.8
- 13Clinico Medical Sp. z o.o.Blonie/Miekinia Dolnoslaskie0 lines1 registrationsize 28.1
- 14Stryker Poland Manufacturing Sp. z o.o.Skawina Malopolskie0 lines1 registrationsize 27.6
- 15BESTER MEDICAL SYSTEM SP. Z O. O.Nowa Deba Podkarpackie0 lines1 registrationsize 25.1
- 16VERDENT LTD.LODZ Lodzkie0 lines1 registrationsize 24.1
- 17CLUNAS AGTarnowo Podgorne Wielkopolskie0 lines1 registrationsize 22.8
- 18BERGER & KRAFTRASZYN Mazowieckie0 lines1 registrationsize 22.0
- 19GOOD MEDICA SP.ZO.O.Wroclaw Dolnoslaskie0 lines1 registrationsize 20.0
- 20JAGO-PRO SP. Z O.O.JAWORZNO Slaskie0 lines1 registrationsize 20.0
See Germany: 880 independent distributors
Distributor in Poland? Add your company, free
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 | 10 | 31% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 3 | 9% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 2 | 6% | 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 | 81% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 2 | 6% | 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 register separately in EUDAMED. Distributors do not register there, which is why the Index lists few EU distributors. Neither owns the CE file, so 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 surgery and endoscopy distributors in Poland
How many surgery and endoscopy distributors are there in Poland?
The Index counts 32 establishments in Poland with surgery and endoscopy in their registry record, of which 3 are independent distributors (a channel role and no manufacturing of their own). EUDAMED does not list distributors, so the Index only sees the 3 independent distributors tagged surgery and endoscopy that appear as importers or in other registries. The real number is higher. The number comes from US FDA (openFDA), EUDAMED, MHRA UK and Health Canada and was last refreshed on 23 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 register separately in EUDAMED. Distributors do not register there, which is why the Index lists few EU distributors. Neither owns the CE file, so 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 see the names, free, no sign-up. For a ranked shortlist for your device, see 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.
How are CE-marked and FDA-cleared surgery and endoscopy devices registered in Poland?
With CE marking: your CE marking is the market authorisation. With FDA clearance: CE marking needed first; FDA clearance alone is not accepted here. No local holder is needed for a maker based inside this regulatory area. CE marking under the MDR is the market authorisation; no national approval. A non-EU maker needs an EU authorised representative. Confirm with a regulatory specialist before you plan a launch date.
How big is the surgery and endoscopy market in Poland?
Health spending in Poland was USD 73.6bn in 2024 (World Bank). Bastion Hale estimates the surgery and endoscopy market at about USD 530m to 870m a year at manufacturer prices. This is a model estimate with low confidence: health spending times the device share of health spending times the segment's share of world medical technology spending. The methodology page shows every input and source.
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 23 October 2026. US government work, public domain.
- EUDAMED economic operator registration, European Commission public API: 13 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- UK MHRA Public Access Registration Database (PARD): 2 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 1 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- Company website (the establishment's own public site): 6 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.