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: 6 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 9 manufacturers' own import or sales entities, 1 regulatory representatives, and 23 manufacturers or exporters, out of 942 medical device establishments in Sweden 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 | 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 6 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 | Mikronmed AB kristianstad | Distributor Importer, Authorised representative | Aesthetics, dermatology and lasers, Dental, Ear, nose and throat +5 more | 0 | 0 | 24 | 24.2 | 4/5 |
| 2 | BioNordika AB Solna | Distributor Importer | Anaesthesia and respiratory, Cardiovascular, In-vitro diagnostics +3 more | 0 | 0 | 2 | 13.9 | 4/5 |
| 3 | JB Nordic AB Nacka | Distributor Importer | General hospital and consumables, Dental, Orthopaedics, spine and trauma | 0 | 0 | 2 | 13.9 | 4/5 |
| 4 | Go North Medical AB Sävedalen | Distributor Importer, Authorised representative | Cardiovascular, Patient monitoring and neurology, Orthopaedics, spine and trauma +1 more | 0 | 0 | 1 | 14.6 | 4/5 |
| 5 | LELOi AB Stockholm | Distributor Importer, Authorised representative | General hospital and consumables, Patient monitoring and neurology, Orthopaedics, spine and trauma | 0 | 0 | 0 | 11.9 | 3/5 |
| 6 | Comfort Medical AB Landskrona | Distributor Importer | General hospital and consumables, Patient monitoring and neurology, Orthopaedics, spine and trauma +1 more | 0 | 0 | 0 | 9.7 | 3/5 |
Include manufacturers, their own sales entities and regulatory representatives (33)
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 | LINK Sweden AB Åkersberga | Maker's own entity Importer | In-vitro diagnostics, Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy +1 more | 0 | 0 | 3 | 15.0 | 4/5 |
| 2 | Go North Medical Derma AB Mölndal | Maker's own entity Importer | Cardiovascular, Patient monitoring and neurology, Orthopaedics, spine and trauma +1 more | 0 | 0 | 1 | 12.3 | 4/5 |
| 3 | Mölnlycke Health Care AB Mölndal | Maker's own entity Importer, Distributor, Registration holder, Manufacturer | General hospital and consumables, Ophthalmic, Orthopaedics, spine and trauma +1 more | 62 | 69 | 0 | 63.5 | 3/5 |
| 4 | Atos Medical AB Hörby | Maker's own entity Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, General hospital and consumables, Ear, nose and throat +3 more | 65 | 36 | 0 | 59.5 | 4/5 |
| 5 | Elekta Solutions AB Stockholm | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Cardiovascular, General hospital and consumables, Patient monitoring and neurology +3 more | 100 | 24 | 0 | 61.0 | 3/5 |
| 6 | Oticon Medical AB Askim | Maker's own entity Distributor, Registration holder, Manufacturer | General hospital and consumables, Ear, nose and throat, Orthopaedics, spine and trauma +1 more | 27 | 8 | 0 | 48.4 | 4/5 |
| 7 | AprioMed AB Uppsala | Maker's own entity Importer, Registration holder, Manufacturer | Gastroenterology, urology and OB/GYN, Orthopaedics, spine and trauma, Surgery and endoscopy | 6 | 7 | 0 | 40.9 | 3/5 |
| 8 | EOE Eyewear AB Stockholm | Maker's own entity Importer | Ophthalmic, Orthopaedics, spine and trauma | 0 | 0 | 0 | 9.7 | 3/5 |
| 9 | Hamamatsu Photonics Norden AB Kista | Maker's own entity Importer | Patient monitoring and neurology, Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy | 0 | 0 | 0 | 9.7 | 3/5 |
| 10 | Nobel Biocare AB Göteborg | Manufacturer Registration holder, Manufacturer | Aesthetics, dermatology and lasers, General hospital and consumables, Dental +3 more | 549 | 55 | 0 | 70.5 | 3/5 |
| 11 | Cochlear Bone Anchored Solutions AB Mölnlycke | Manufacturer Registration holder, Manufacturer | General hospital and consumables, Ear, nose and throat, Orthopaedics, spine and trauma +1 more | 69 | 24 | 0 | 56.3 | 3/5 |
| 12 | Q-Med AB Uppsala, Uppsala Län | Manufacturer Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Gastroenterology, urology and OB/GYN, Orthopaedics, spine and trauma +1 more | 24 | 11 | 0 | 47.6 | 3/5 |
| 13 | Integrum AB Mölndal | Manufacturer Manufacturer, Exporter | Patient monitoring and neurology, Orthopaedics, spine and trauma | 7 | 8 | 0 | 38.6 | 4/5 |
| 14 | Sectra AB Linkoping | Manufacturer Registration holder, Manufacturer | In-vitro diagnostics, Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy | 4 | 7 | 0 | 37.6 | 4/5 |
| 15 | BONESUPPORT AB Lund | Manufacturer Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Orthopaedics, spine and trauma | 3 | 5 | 0 | 33.2 | 4/5 |
| 16 | Episurf Operations AB Stockholm | Manufacturer Manufacturer | Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy | 2 | 2 | 0 | 26.2 | 3/5 |
| 17 | Stille AB Torshälla | Manufacturer Manufacturer | Cardiovascular, General hospital and consumables, Ear, nose and throat +6 more | 39 | 1 | 0 | 37.4 | 4/5 |
| 18 | CENOVA AB MJOLBY Ostergotland | Manufacturer Manufacturer | Dental, Ear, nose and throat, Gastroenterology, urology and OB/GYN +3 more | 24 | 1 | 0 | 29.2 | 3/5 |
| 19 | ELOS MEDTECH TIMMERSDALA AB TIMMERSDALA Vastra Gotaland | Manufacturer Manufacturer | Dental, Ear, nose and throat, Patient monitoring and neurology +2 more | 19 | 1 | 0 | 28.1 | 3/5 |
| 20 | Meloq AB STOCKHOLM | Manufacturer Manufacturer | Patient monitoring and neurology, Orthopaedics, spine and trauma | 3 | 1 | 0 | 25.8 | 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 6 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 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 23 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.
- UK MHRA Public Access Registration Database (PARD): 15 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 10 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- Company website (the establishment's own public site): 11 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.