Updated 22 October 2026
Orthopaedic and spine device distributors in the Netherlands: 44 licensed establishments
The Bastion Hale Distributor Index lists 44 establishments in the Netherlands whose registry records include orthopaedics, spine and trauma: 4 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 19 manufacturers' own import or sales entities, 0 regulatory representatives, and 21 manufacturers or exporters, out of 2,064 medical device establishments in the Netherlands overall. The records come from US FDA (openFDA), EUDAMED, MHRA UK and Health Canada, 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 | 21 | 48% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 1 | 2% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 18 | 41% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 4 | 9% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 21 | 48% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 17 | 39% | 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 the Netherlands
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 4 independent orthopaedics, spine and trauma distributors
Independent distributors only, ranked by the other manufacturers' lines they carry, then registrations held, then size.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | Addex Medical B.V. Helmond | Distributor Importer, Authorised representative | Cardiovascular, General hospital and consumables, Gastroenterology, urology and OB/GYN +5 more | 0 | 0 | 1 | 14.6 | 4/5 |
| 2 | Active Aligners Netherlands Amsterdam, Netherlands | Distributor Importer, Authorised representative | Dental, Orthopaedics, spine and trauma, Surgery and endoscopy | 0 | 0 | 0 | 11.9 | 3/5 |
| 3 | Hopeway AMD B.V. Rotterdam | Distributor Importer, Authorised representative | Anaesthesia and respiratory, General hospital and consumables, Dental +4 more | 0 | 0 | 0 | 11.9 | 3/5 |
| 4 | Medical Workshop BV Groningen | Distributor Importer, Authorised representative | General hospital and consumables, Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy +1 more | 0 | 0 | 0 | 11.9 | 3/5 |
Include manufacturers, their own sales entities and regulatory representatives (40)
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.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | Medical Measurement Systems B.V. Hengelo | Maker's own entity Importer, Authorised representative, Exporter | Aesthetics, dermatology and lasers, Cardiovascular, General hospital and consumables +6 more | 8 | 1 | 2 | 35.5 | 5/5 |
| 2 | Smith & Nephew Operations BV Hoofddorp | Maker's own entity Importer, Authorised representative | General hospital and consumables, Orthopaedics, spine and trauma, Surgery and endoscopy | 0 | 0 | 2 | 16.1 | 4/5 |
| 3 | TANITA Europe B.V. AMSTERDAM | Maker's own entity Importer, Authorised representative | Patient monitoring and neurology, Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy | 0 | 0 | 1 | 14.6 | 4/5 |
| 4 | Philips Medical Systems Nederland B.V. Best | Maker's own entity Importer, Authorised representative, Registration holder, Manufacturer, Exporter | Cardiovascular, General hospital and consumables, Dental +6 more | 529 | 129 | 0 | 78.2 | 3/5 |
| 5 | Nucletron B.V. Veenendaal | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Cardiovascular, General hospital and consumables, Gastroenterology, urology and OB/GYN +4 more | 126 | 38 | 0 | 64.3 | 3/5 |
| 6 | MENTOR MEDICAL SYSTEMS, B.V. Leiden | Maker's own entity Authorised representative, Registration holder, Manufacturer | Orthopaedics, spine and trauma | 31 | 8 | 0 | 47.3 | 3/5 |
| 7 | Arthrex Distribution Hub EMEA B.V. Venlo | Maker's own entity Importer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +6 more | 304 | 1 | 0 | 47.6 | 3/5 |
| 8 | Biomet Global Supply Chain Center B.V. Breda | Maker's own entity Importer, Authorised representative, Exporter | Anaesthesia and respiratory, Dental, Orthopaedics, spine and trauma +1 more | 208 | 1 | 0 | 47.3 | 4/5 |
| 9 | Merit Medical Nederland BV Maastricht Airport | Maker's own entity Importer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 263 | 1 | 0 | 46.8 | 4/5 |
| 10 | Stryker EMEA Supply Chain Services BV Venlo | Maker's own entity Importer, Manufacturer, Exporter | Cardiovascular, General hospital and consumables, Ear, nose and throat +5 more | 129 | 1 | 0 | 44.9 | 4/5 |
| 11 | Essity Distribution B.V. Zeist | Maker's own entity Importer, Exporter | General hospital and consumables, Patient monitoring and neurology, Orthopaedics, spine and trauma +1 more | 51 | 1 | 0 | 38.6 | 3/5 |
| 12 | ZOLL International Holding B.V. Elst | Maker's own entity Importer, Authorised representative, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +4 more | 25 | 1 | 0 | 36.7 | 4/5 |
| 13 | OTN Implants B.V. Arnhem | Maker's own entity Distributor, Authorised representative, Manufacturer | Patient monitoring and neurology, Orthopaedics, spine and trauma, Surgery and endoscopy | 4 | 1 | 0 | 28.4 | 4/5 |
| 14 | AngioDynamics Netherlands BV Amsterdam | Maker's own entity Importer, Authorised representative | Cardiovascular, General hospital and consumables, Gastroenterology, urology and OB/GYN +4 more | 0 | 0 | 0 | 11.9 | 3/5 |
| 15 | AtriCure Europe B.V. Amsterdam | Maker's own entity Importer, Authorised representative | Cardiovascular, Orthopaedics, spine and trauma, Surgery and endoscopy | 0 | 0 | 0 | 11.9 | 3/5 |
| 16 | Canon Medical Systems Europe B.V. Amstelveen | Maker's own entity Importer, Authorised representative | Cardiovascular, Patient monitoring and neurology, Orthopaedics, spine and trauma +1 more | 0 | 0 | 0 | 11.9 | 3/5 |
| 17 | Corpus Plus BV Woubrugge | Maker's own entity Importer, Authorised representative | Orthopaedics, spine and trauma | 0 | 0 | 0 | 11.9 | 3/5 |
| 18 | OTC Medical B.V. Arnhem | Maker's own entity Importer, Authorised representative | Ophthalmic, Orthopaedics, spine and trauma | 0 | 0 | 0 | 11.9 | 3/5 |
| 19 | SILIMED B.V. Eindhoven | Maker's own entity Importer, Authorised representative | Ear, nose and throat, Orthopaedics, spine and trauma | 0 | 0 | 0 | 11.9 | 3/5 |
| 20 | 4WEB EU B.V. Assendelft, Noord-Holland | Manufacturer Manufacturer, Exporter | Orthopaedics, spine and trauma | 26 | 5 | 0 | 42.9 | 4/5 |
Questions about orthopaedics, spine and trauma distributors in the Netherlands
How many orthopaedics, spine and trauma distributors are there in the Netherlands?
The Index counts 44 establishments in the Netherlands with orthopaedics, spine and trauma in their registry record, of which 4 are independent distributors (a channel role and no manufacturing of their own). The number comes from US FDA (openFDA), EUDAMED, MHRA UK and Health Canada and was last refreshed on 22 October 2026.
Who can hold a orthopaedics, spine and trauma device registration in the Netherlands?
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 the Netherlands?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and the Netherlands 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 the Netherlands?
A company that appears in a public regulatory registry with an address in the Netherlands 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 the Netherlands
Orthopaedics, spine and trauma in other EU and EEA markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 30 establishments, last seen 23 October 2026. US government work, public domain.
- EUDAMED economic operator registration, European Commission public API: 29 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- UK MHRA Public Access Registration Database (PARD): 8 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 4 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- Company website (the establishment's own public site): 14 establishments, last seen 23 October 2026. Enrichment, not a registry: segments and principals read from the company's own website.
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.