Updated 22 October 2026
Medical device distributors in Sweden: 927 licensed establishments
The Bastion Hale Distributor Index lists 927 medical device establishments registered with an address in Sweden: 310 with a channel role (importer, distributor, wholesaler or authorised representative), 25 registration holders without a channel role, and 592 registered as manufacturer or exporter only. The records come from EUDAMED, US FDA (openFDA) and Health Canada, last seen on 22 October 2026.
By segment
Segments come from the device listings linked to each establishment, so one company can appear in several rows. Imaging and radiology are shown because the registries contain them; Bastion Hale's launch services do not cover them.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 271 | 29% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 8 | 1% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 54 | 6% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 43 | 5% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 692 | 75% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 32 | 3% | 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.
This is the general rule, not legal advice. The registration clause in the first distributor contract decides who controls the market later; the Audit covers it per market.
Top 20 establishments by size
Channel roles (importer, distributor, wholesaler, authorised representative) are listed first, then registration holders, then manufacturers. Size is a 0 to 100 score built from products listed, registrations held, roles, sources and principals represented. Complete is 0 to 5 for website, address, segments, principals and counts.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | Phadia AB Uppsala | Channel Importer, Registration holder, Manufacturer | Cardiovascular, In-vitro diagnostics | 252 | 16 | 0 | 60.7 | 4/5 |
| 2 | 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 |
| 3 | MAQUET Critical Care AB Solna | Channel Importer, Authorised representative, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +3 more | 140 | 14 | 0 | 59.4 | 4/5 |
| 4 | 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 |
| 5 | 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 |
| 6 | ArjoHuntleigh AB Malmö | Channel Importer, Registration holder, Manufacturer | Patient monitoring and neurology | 76 | 19 | 0 | 55.5 | 4/5 |
| 7 | Vitrolife Sweden AB Göteborg | Channel Distributor, Registration holder, Manufacturer | Anaesthesia and respiratory, General hospital and consumables, Gastroenterology, urology and OB/GYN +1 more | 40 | 36 | 0 | 55.2 | 4/5 |
| 8 | Breas Medical AB MÖLNLYCKE | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +1 more | 63 | 9 | 0 | 52.5 | 4/5 |
| 9 | HemoCue AB Ängelholm | Channel Importer, Registration holder, Manufacturer | In-vitro diagnostics | 24 | 9 | 0 | 46.5 | 4/5 |
| 10 | Cepheid AB Solna | Channel Importer, Authorised representative, Registration holder, Manufacturer | In-vitro diagnostics | 21 | 7 | 0 | 46.0 | 4/5 |
| 11 | 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 |
| 12 | Wellspect HealthCare Mölndal | Channel Importer, Registration holder, Manufacturer | Cardiovascular, General hospital and consumables, Dental +2 more | 34 | 4 | 0 | 44.9 | 4/5 |
| 13 | ABIGO Medical AB Göteborg | Channel Importer, Registration holder, Manufacturer | General hospital and consumables | 12 | 13 | 0 | 44.8 | 4/5 |
| 14 | CareDx AB Stockholm | Channel Importer, Registration holder, Manufacturer | No segment in record | 27 | 3 | 0 | 42.8 | 2/5 |
| 15 | Directa AB Upplands Vasby | Channel Importer, Authorised representative, Manufacturer, Exporter | Anaesthesia and respiratory, Dental, Surgery and endoscopy | 35 | 1 | 0 | 39.6 | 4/5 |
| 16 | NaturalCycles Nordic AB Stockholm | Channel Distributor, Authorised representative, Registration holder, Manufacturer, Exporter | Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 9 | 2 | 0 | 38.4 | 4/5 |
| 17 | Neoss AB Gothenburg | Channel Importer, Manufacturer, Exporter | General hospital and consumables, Dental, Surgery and endoscopy | 23 | 1 | 0 | 36.3 | 3/5 |
| 18 | Etac Supply Center AB Anderstorp | Channel Importer, Authorised representative, Manufacturer | Patient monitoring and neurology | 18 | 1 | 0 | 35.1 | 4/5 |
| 19 | Essity Hygiene and Health AB Göteborg | Channel Importer, Registration holder, Manufacturer | General hospital and consumables, Gastroenterology, urology and OB/GYN | 5 | 3 | 0 | 35.0 | 4/5 |
| 20 | 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 |
Questions about medical device distributors in Sweden
How many medical device distributors are there in Sweden?
The Index counts 927 medical device establishments registered in Sweden, of which 310 hold a channel role as importer, distributor, wholesaler or authorised representative. The rest are registration holders or manufacturers. The number comes from EUDAMED, US FDA (openFDA) and Health Canada and was last refreshed on 22 October 2026.
Who can hold a medical 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 medical device distributor in Sweden?
Start with the segment table on this page, open the top establishments and check their roles, principals and registration counts. Then search the Index for your device and Sweden to see the counts for your segment and reveal three profiles. For a shortlist with our read on each name, book the International Launch Audit.
What does the Distributor Index count as a distributor in Sweden?
An establishment is a company that appears in a public regulatory registry with an address in Sweden, in any of the roles importer, distributor, wholesaler, authorised representative, sponsor, registration holder, manufacturer or exporter. Each company is counted once per country even if it holds several licences or appears in several registries. No contacts or named individuals are collected.
Segment pages for Sweden
Related markets in EU and EEA
Sources
- EUDAMED economic operator registration, European Commission public API: 860 establishments, last seen 22 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 194 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 48 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.