Updated 22 October 2026
Orthopaedic and spine device distributors in Sweden: 39 licensed establishments
The Bastion Hale Distributor Index lists 39 establishments in Sweden whose registry records include orthopaedics, spine and trauma: 16 with a channel role (importer, distributor, wholesaler or authorised representative), 5 registration holders without a channel role, and 18 registered as manufacturer or exporter only, out of 927 medical device establishments in Sweden overall. The records come from US FDA (openFDA), EUDAMED, web 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 | 14 | 36% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 2 | 5% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 4 | 10% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 10 | 26% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 28 | 72% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 3 | 8% | 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 Sweden
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 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 | Mölnlycke Health Care AB Mölndal | Channel Importer, Distributor, Registration holder, Manufacturer | General hospital and consumables, Ophthalmic, Orthopaedics, spine and trauma +1 more | 62 | 52 | 0 | 60.3 | 3/5 |
| 2 | Elekta Solutions AB Stockholm | Channel Importer, Registration holder, Manufacturer, Exporter | Cardiovascular, General hospital and consumables, Patient monitoring and neurology +3 more | 100 | 22 | 0 | 58.7 | 3/5 |
| 3 | Atos Medical AB Hörby | Channel Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, General hospital and consumables, Ear, nose and throat +3 more | 65 | 24 | 0 | 55.7 | 4/5 |
| 4 | Oticon Medical AB Askim | Channel Distributor, Registration holder, Manufacturer | General hospital and consumables, Ear, nose and throat, Orthopaedics, spine and trauma +1 more | 27 | 6 | 0 | 45.4 | 4/5 |
| 5 | AprioMed AB Uppsala | Channel Importer, Registration holder, Manufacturer | Gastroenterology, urology and OB/GYN, Orthopaedics, spine and trauma, Surgery and endoscopy | 6 | 2 | 0 | 34.4 | 3/5 |
| 6 | Mikronmed AB kristianstad | Channel Importer, Authorised representative | Aesthetics, dermatology and lasers, Dental, Ear, nose and throat +5 more | 0 | 0 | 24 | 27.6 | 4/5 |
| 7 | BioNordika AB Solna | Channel Importer | Anaesthesia and respiratory, Cardiovascular, In-vitro diagnostics +3 more | 0 | 0 | 3 | 18.4 | 4/5 |
| 8 | JB Nordic AB Nacka | Channel Importer | General hospital and consumables, Dental, Orthopaedics, spine and trauma | 0 | 0 | 3 | 18.4 | 4/5 |
| 9 | LINK Sweden AB Åkersberga | Channel Importer | In-vitro diagnostics, Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy +1 more | 0 | 0 | 3 | 18.4 | 4/5 |
| 10 | Go North Medical AB Sävedalen | Channel Importer, Authorised representative | Cardiovascular, Patient monitoring and neurology, Orthopaedics, spine and trauma +1 more | 0 | 0 | 1 | 18.0 | 4/5 |
| 11 | Comfort Medical AB Landskrona | Channel Importer | General hospital and consumables, Patient monitoring and neurology, Orthopaedics, spine and trauma +1 more | 0 | 0 | 2 | 17.3 | 4/5 |
| 12 | InterV Nordic AB Sollentuna | Channel Authorised representative | Orthopaedics, spine and trauma | 0 | 0 | 2 | 17.3 | 4/5 |
| 13 | Go North Medical Derma AB Mölndal | Channel Importer | Cardiovascular, Patient monitoring and neurology, Orthopaedics, spine and trauma +1 more | 0 | 0 | 1 | 15.7 | 4/5 |
| 14 | Hamamatsu Photonics Norden AB Kista | Channel Importer | Patient monitoring and neurology, Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy | 0 | 0 | 1 | 15.7 | 4/5 |
| 15 | LELOi AB Stockholm | Channel Importer, Authorised representative | General hospital and consumables, Patient monitoring and neurology, Orthopaedics, spine and trauma | 0 | 0 | 0 | 15.3 | 3/5 |
| 16 | EOE Eyewear AB Stockholm | Channel Importer | Ophthalmic, Orthopaedics, spine and trauma | 0 | 0 | 0 | 13.1 | 3/5 |
| 17 | Nobel Biocare AB Göteborg | Holder Registration holder, Manufacturer | Aesthetics, dermatology and lasers, General hospital and consumables, Dental +3 more | 549 | 51 | 0 | 68.3 | 3/5 |
| 18 | Cochlear Bone Anchored Solutions AB Mölnlycke | Holder Registration holder, Manufacturer | General hospital and consumables, Ear, nose and throat, Orthopaedics, spine and trauma +1 more | 69 | 10 | 0 | 50.6 | 3/5 |
| 19 | Q-Med AB Uppsala | Holder Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Gastroenterology, urology and OB/GYN, Orthopaedics, spine and trauma +1 more | 24 | 10 | 0 | 45.3 | 3/5 |
| 20 | Sectra AB Linkoping | Holder Registration holder, Manufacturer | In-vitro diagnostics, Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy | 4 | 4 | 0 | 33.5 | 4/5 |
Questions about orthopaedics, spine and trauma distributors in Sweden
How many orthopaedics, spine and trauma distributors are there in Sweden?
The Index counts 39 establishments in Sweden with orthopaedics, spine and trauma in their registry record, of which 16 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 orthopaedics, spine and trauma device registration in Sweden?
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 Sweden?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Sweden 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 Sweden?
A company that appears in a public regulatory registry with an address in Sweden 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 Sweden
Orthopaedics, spine and trauma in other EU and EEA markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 27 establishments, last seen 22 October 2026. US government work, public domain.
- EUDAMED economic operator registration, European Commission public API: 26 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- web (public register): 11 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 10 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.