Updated 22 October 2026
ENT device distributors in Sweden: 23 licensed establishments
The Bastion Hale Distributor Index lists 23 establishments in Sweden whose registry records include ear, nose and throat: 9 with a channel role (importer, distributor, wholesaler or authorised representative), 1 registration holders without a channel role, and 13 registered as manufacturer or exporter only, out of 927 medical device establishments in Sweden overall. The records come from US FDA (openFDA), EUDAMED, Health Canada and web, last seen on 23 October 2026.
Ear, nose and throat covers hearing devices, cochlear implants, sinus and laryngology instruments, and audiology equipment. Hearing aids often go through retail audiology chains rather than hospital distributors, so the establishment list mixes both. Volumes per establishment are smaller than in surgery.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 7 | 30% | 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 | 13% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 6 | 26% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 20 | 87% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 3 | 13% | 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 ear, nose and throat 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 | 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 |
| 2 | 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 |
| 3 | 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 |
| 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 | Wellspect HealthCare Mölndal | Channel Importer, Registration holder, Manufacturer | Cardiovascular, General hospital and consumables, Dental +2 more | 34 | 4 | 0 | 44.9 | 4/5 |
| 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 | Mediplast AB Malmö | Channel Importer, Manufacturer | General hospital and consumables, Dental, Ear, nose and throat +1 more | 4 | 1 | 0 | 26.7 | 4/5 |
| 8 | Bo Edin AB Lidingö | Channel Authorised representative | General hospital and consumables, Ear, nose and throat | 0 | 0 | 0 | 13.1 | 3/5 |
| 9 | FISHER & PAYKEL HEALTHCARE AB SOLNA | Channel Importer | Anaesthesia and respiratory, Ear, nose and throat, Patient monitoring and neurology +1 more | 0 | 0 | 0 | 13.1 | 3/5 |
| 10 | 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 |
| 11 | Dentsply IH AB MOLNDAL Vastra Gotaland | Manufacturer Manufacturer, Exporter | General hospital and consumables, Dental, Ear, nose and throat | 58 | 1 | 0 | 35.9 | 3/5 |
| 12 | Stille AB Torshälla | Manufacturer Manufacturer | Cardiovascular, General hospital and consumables, Ear, nose and throat +6 more | 39 | 1 | 0 | 35.0 | 4/5 |
| 13 | SVENSKA DENTORAMA AB Sollentuna / Stockholm | Manufacturer Manufacturer | Dental, Ear, nose and throat, Surgery and endoscopy | 13 | 1 | 0 | 29.7 | 4/5 |
| 14 | 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 |
| 15 | 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 |
| 16 | Aurena Laboratories AB Karlstad | Manufacturer Manufacturer | Ear, nose and throat, Surgery and endoscopy | 3 | 1 | 0 | 23.4 | 4/5 |
| 17 | AMB INDUSTRI AB Broakulla Kalmar | Manufacturer Manufacturer | Cardiovascular, Ear, nose and throat | 5 | 1 | 0 | 22.0 | 3/5 |
| 18 | Circius Pharma AB Askim | Manufacturer Manufacturer | Ear, nose and throat | 2 | 1 | 0 | 21.9 | 4/5 |
| 19 | Inission Syd AB (Malmo AB) Malmo Skane | Manufacturer Manufacturer | Ear, nose and throat | 3 | 1 | 0 | 20.0 | 3/5 |
| 20 | ATE PHARMACARE AB Goteborg Vastra Gotaland | Manufacturer Manufacturer | Ear, nose and throat | 2 | 1 | 0 | 18.5 | 3/5 |
Questions about ear, nose and throat distributors in Sweden
How many ear, nose and throat distributors are there in Sweden?
The Index counts 23 establishments in Sweden with ear, nose and throat in their registry record, of which 9 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from US FDA (openFDA), EUDAMED, Health Canada and web and was last refreshed on 22 October 2026.
Who can hold a ear, nose and throat 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 ear, nose and throat 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 ear, nose and throat 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 ear, nose and throat 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
Ear, nose and throat in other EU and EEA markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 20 establishments, last seen 22 October 2026. US government work, public domain.
- EUDAMED economic operator registration, European Commission public API: 14 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 6 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
- web (public register): 3 establishments, last seen 23 October 2026. Public register.
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.