Updated 22 October 2026
Orthopaedic and spine device distributors in Poland: 17 licensed establishments
The Bastion Hale Distributor Index lists 17 establishments in Poland whose registry records include orthopaedics, spine and trauma: 6 with a channel role (importer, distributor, wholesaler or authorised representative), 0 registration holders without a channel role, and 11 registered as manufacturer or exporter only, out of 1,583 medical device establishments in Poland overall. The records come from US FDA (openFDA), EUDAMED and web, last seen on 23 October 2026.
Orthopaedics covers implants for joints, spine and trauma, together with instruments and bone substitutes. Implants are usually Class IIb or III, so the importer or registration holder carries real regulatory work and hospitals often buy through tenders. Distributors in this segment tend to employ clinical support staff who attend surgery.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 5 | 29% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Authorised representative | 2 | 12% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Manufacturer | 13 | 76% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 1 | 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 and distributors register separately as economic operators and never own the registration, which is why EU channel changes are easier than elsewhere.
Top 17 orthopaedics, spine and trauma 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 | 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 |
| 2 | 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 |
| 3 | Bertz Medical Spółka z ograniczoną odpowiedzialnością Spółka komandytowa Komorniki | Channel Importer | Gastroenterology, urology and OB/GYN, Patient monitoring and neurology, Orthopaedics, spine and trauma +1 more | 0 | 0 | 10 | 22.2 | 4/5 |
| 4 | Dental for Children Prosta Spółka Akcyjna Reda | Channel Importer | Dental, Orthopaedics, spine and trauma | 0 | 0 | 5 | 19.9 | 4/5 |
| 5 | FM Produkty dla Stomatologii Wojciech Feć, Maciej Feć sp.j. Kraków | Channel Importer | Cardiovascular, Orthopaedics, spine and trauma | 0 | 0 | 3 | 18.4 | 4/5 |
| 6 | Vitafon PL Leonids Berkovičs Warszawa | Channel Importer, Authorised representative | Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy | 0 | 0 | 0 | 15.3 | 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 | ArjoHuntleigh Polska Sp. zo.o. Poznan Wielkopolskie | Manufacturer Manufacturer, Exporter | Cardiovascular, General hospital and consumables, Patient monitoring and neurology +1 more | 35 | 1 | 0 | 33.4 | 3/5 |
| 9 | AMETEK Poland sp. z o.o. Siechnice Dolnoslaskie | Manufacturer Manufacturer | Orthopaedics, spine and trauma, Surgery and endoscopy | 22 | 1 | 0 | 28.8 | 3/5 |
| 10 | 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 |
| 11 | 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 |
| 12 | BHH Mikromed Dabrowa Gornicza | Manufacturer Manufacturer | Orthopaedics, spine and trauma | 6 | 1 | 0 | 26.2 | 4/5 |
| 13 | 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 |
| 14 | ENSINGER COMPOSITES MACHINING SP. Z O.O. Dobra Zachodniopomorskie | Manufacturer Manufacturer | Orthopaedics, spine and trauma | 6 | 1 | 0 | 22.8 | 3/5 |
| 15 | GOOD MEDICA SP.ZO.O. Wroclaw Dolnoslaskie | Manufacturer Manufacturer | Patient monitoring and neurology, Orthopaedics, spine and trauma, Surgery and endoscopy | 3 | 1 | 0 | 20.0 | 3/5 |
| 16 | Nolato Stargard Sp. z o.o. Stargard Zachodniopomorskie | Manufacturer Manufacturer | Gastroenterology, urology and OB/GYN, Orthopaedics, spine and trauma | 3 | 1 | 0 | 20.0 | 3/5 |
| 17 | PAUL HARTMANN Manufacturing Sp. z o.o. Libidza Dolnoslaskie | Manufacturer Manufacturer | General hospital and consumables, Orthopaedics, spine and trauma, Surgery and endoscopy | 3 | 1 | 0 | 20.0 | 3/5 |
Questions about orthopaedics, spine and trauma distributors in Poland
How many orthopaedics, spine and trauma distributors are there in Poland?
The Index counts 17 establishments in Poland with orthopaedics, spine and trauma in their registry record, of which 6 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from US FDA (openFDA), EUDAMED and web and was last refreshed on 22 October 2026.
Who can hold a orthopaedics, spine and trauma 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 orthopaedics, spine and trauma 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 orthopaedics, spine and trauma 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 orthopaedics, spine and trauma 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
Orthopaedics, spine and trauma in other EU and EEA markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 13 establishments, last seen 22 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.
- web (public register): 4 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.