Updated 22 October 2026
In-vitro diagnostics distributors in Sweden: 26 licensed establishments
The Bastion Hale Distributor Index lists 26 establishments in Sweden whose registry records include in-vitro diagnostics: 6 with a channel role (importer, distributor, wholesaler or authorised representative), 5 registration holders without a channel role, and 15 registered as manufacturer or exporter only, out of 927 medical device establishments in Sweden overall. The records come from US FDA (openFDA), EUDAMED and Health Canada, last seen on 22 October 2026.
In-vitro diagnostics covers analysers, reagents, rapid tests and laboratory consumables across chemistry, haematology, microbiology, immunology and genetics. IVD has its own regulation in most markets, and the EU regulates it under IVDR rather than MDR. Laboratory distributors usually differ from device distributors, even inside the same company.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 5 | 19% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 1 | 4% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 3 | 12% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 10 | 38% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 26 | 100% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 5 | 19% | 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 in-vitro diagnostics 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 | Phadia AB Uppsala | Channel Importer, Registration holder, Manufacturer | Cardiovascular, In-vitro diagnostics | 252 | 16 | 0 | 60.7 | 4/5 |
| 2 | 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 |
| 3 | HemoCue AB Ängelholm | Channel Importer, Registration holder, Manufacturer | In-vitro diagnostics | 24 | 9 | 0 | 46.5 | 4/5 |
| 4 | Cepheid AB Solna | Channel Importer, Authorised representative, Registration holder, Manufacturer | In-vitro diagnostics | 21 | 7 | 0 | 46.0 | 4/5 |
| 5 | 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 |
| 6 | Boule Medical AB Spånga | Channel Importer, Manufacturer, Exporter | In-vitro diagnostics | 5 | 1 | 0 | 29.3 | 4/5 |
| 7 | Mercodia AB UPPSALA | Holder Registration holder, Manufacturer | In-vitro diagnostics | 23 | 11 | 0 | 45.6 | 4/5 |
| 8 | CellaVision AB Lund | Holder Registration holder, Manufacturer, Exporter | General hospital and consumables, In-vitro diagnostics | 26 | 5 | 0 | 44.5 | 4/5 |
| 9 | Nidacon International AB Mölndal | Holder Registration holder, Manufacturer | Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 13 | 11 | 0 | 42.8 | 4/5 |
| 10 | 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 |
| 11 | Svar Life Science AB Malmö | Holder Registration holder, Manufacturer | In-vitro diagnostics | 3 | 3 | 0 | 31.3 | 4/5 |
| 12 | Fujirebio Diagnostics, AB Mölndal | Manufacturer Manufacturer | In-vitro diagnostics | 4 | 2 | 0 | 26.4 | 4/5 |
| 13 | NIOX AB Uppsala | Manufacturer Manufacturer | In-vitro diagnostics | 6 | 1 | 0 | 26.2 | 3/5 |
| 14 | M Dialysis AB Stockholm | Manufacturer Manufacturer | In-vitro diagnostics, Patient monitoring and neurology, Surgery and endoscopy | 4 | 1 | 0 | 24.5 | 4/5 |
| 15 | Capitainer AB Solna | Manufacturer Manufacturer, Exporter | In-vitro diagnostics | 2 | 1 | 0 | 24.2 | 4/5 |
| 16 | Miris AB Uppsala | Manufacturer Manufacturer | In-vitro diagnostics | 3 | 1 | 0 | 23.4 | 4/5 |
| 17 | KITRON AB Jonkoping | Manufacturer Manufacturer | Anaesthesia and respiratory, In-vitro diagnostics | 3 | 1 | 0 | 20.0 | 3/5 |
| 18 | SANMINA-SCI AB SJALEVAD Vasternorrland | Manufacturer Manufacturer | Gastroenterology, urology and OB/GYN, In-vitro diagnostics | 3 | 1 | 0 | 20.0 | 3/5 |
| 19 | Conroy Medical AB Upplands Vaesby | Manufacturer Manufacturer | In-vitro diagnostics | 1 | 1 | 0 | 19.8 | 4/5 |
| 20 | OneTwo Analytics AB Stockholm | Manufacturer Manufacturer | In-vitro diagnostics | 1 | 1 | 0 | 19.8 | 4/5 |
Questions about in-vitro diagnostics distributors in Sweden
How many in-vitro diagnostics distributors are there in Sweden?
The Index counts 26 establishments in Sweden with in-vitro diagnostics in their registry record, of which 6 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from US FDA (openFDA), EUDAMED and Health Canada and was last refreshed on 22 October 2026.
Who can hold a in-vitro diagnostics 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 in-vitro diagnostics 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 shortlist with our read on each name, book the International Launch Audit.
What does the Distributor Index count as a in-vitro diagnostics 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 in-vitro diagnostics 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
In-vitro diagnostics in other EU and EEA markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 26 establishments, last seen 22 October 2026. US government work, public domain.
- EUDAMED economic operator registration, European Commission public API: 20 establishments, last seen 22 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- 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.