Updated 22 October 2026
Orthopaedic and spine device distributors in Denmark: 15 licensed establishments
The Bastion Hale Distributor Index lists 15 establishments in Denmark whose registry records include orthopaedics, spine and trauma: 5 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 6 manufacturers' own import or sales entities, 0 regulatory representatives, and 4 manufacturers or exporters, out of 620 medical device establishments in Denmark overall. The records come from EUDAMED, US FDA (openFDA), Health Canada and MHRA UK, 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 | 10 | 67% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 2 | 13% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 3 | 20% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 7 | 47% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 8 | 53% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 1 | 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 Denmark
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 5 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 | Dansk Nordenta A/S Hørning | Distributor Importer | Dental, Orthopaedics, spine and trauma | 0 | 0 | 2 | 13.9 | 4/5 |
| 2 | Eastwest Medico ApS Charlottenlund | Distributor Importer | Anaesthesia and respiratory, General hospital and consumables, Patient monitoring and neurology +3 more | 0 | 0 | 2 | 13.9 | 4/5 |
| 3 | BMEDIC ApS Fredericia | Distributor Importer | General hospital and consumables, Orthopaedics, spine and trauma | 0 | 0 | 0 | 9.7 | 3/5 |
| 4 | EltiDent ApS Greve | Distributor Importer | Orthopaedics, spine and trauma, Surgery and endoscopy | 0 | 0 | 0 | 9.7 | 3/5 |
| 5 | Metec ApS København S | Distributor Importer | Cardiovascular, Orthopaedics, spine and trauma | 0 | 0 | 0 | 9.7 | 3/5 |
Include manufacturers, their own sales entities and regulatory representatives (10)
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 | Vygon (Denmark) ApS Hellerup | Maker's own entity Importer, Authorised representative | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +3 more | 0 | 0 | 1 | 14.6 | 4/5 |
| 2 | Coloplast A/S Humlebæk | Maker's own entity Importer, Registration holder, Manufacturer | Cardiovascular, General hospital and consumables, Gastroenterology, urology and OB/GYN +2 more | 116 | 72 | 0 | 65.6 | 4/5 |
| 3 | DGS Diagnostics A/S Middelfart | Maker's own entity Importer, Distributor, Authorised representative, Registration holder, Manufacturer | General hospital and consumables, Orthopaedics, spine and trauma | 17 | 14 | 0 | 49.0 | 3/5 |
| 4 | Auditdata A/S Copenhagen | Maker's own entity Distributor, Registration holder, Manufacturer, Exporter | Ear, nose and throat, Orthopaedics, spine and trauma | 12 | 8 | 0 | 45.8 | 4/5 |
| 5 | ErgoDenta ApS Denmark | Maker's own entity Importer, Authorised representative, Manufacturer | Dental, Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy +1 more | 35 | 1 | 0 | 38.4 | 4/5 |
| 6 | Argon Medical Devices Danmark ApS Ballerup | Maker's own entity Importer | Cardiovascular, General hospital and consumables, Ear, nose and throat +5 more | 0 | 0 | 0 | 9.7 | 3/5 |
| 7 | Radiometer Medical ApS Brønshøj | Manufacturer Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +3 more | 134 | 44 | 0 | 62.4 | 4/5 |
| 8 | Natus Medical Denmark ApS Taastrup | Manufacturer Registration holder, Manufacturer | General hospital and consumables, Ear, nose and throat, Patient monitoring and neurology +2 more | 124 | 40 | 0 | 61.6 | 4/5 |
| 9 | 3Shape A/S Copenhagen K | Manufacturer Registration holder, Manufacturer | Dental, Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy | 9 | 11 | 0 | 43.0 | 4/5 |
| 10 | Elos Medtech Pinol A/S Gørløse, Gørløse | Manufacturer Registration holder, Manufacturer | Dental, Ear, nose and throat, Orthopaedics, spine and trauma | 34 | 10 | 0 | 48.9 | 4/5 |
Questions about orthopaedics, spine and trauma distributors in Denmark
How many orthopaedics, spine and trauma distributors are there in Denmark?
The Index counts 15 establishments in Denmark with orthopaedics, spine and trauma in their registry record, of which 5 are independent distributors (a channel role and no manufacturing of their own). The number comes from EUDAMED, US FDA (openFDA), Health Canada and MHRA UK and was last refreshed on 22 October 2026.
Who can hold a orthopaedics, spine and trauma device registration in Denmark?
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 Denmark?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Denmark 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 Denmark?
A company that appears in a public regulatory registry with an address in Denmark 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 Denmark
Orthopaedics, spine and trauma in other EU and EEA markets
Sources
- EUDAMED economic operator registration, European Commission public API: 15 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: 7 establishments, last seen 23 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 7 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- UK MHRA Public Access Registration Database (PARD): 7 establishments, last seen 23 October 2026. Public register.
- Company website (the establishment's own public site): 7 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.