Updated 22 October 2026
ENT device distributors in Denmark: 19 licensed establishments
The Bastion Hale Distributor Index lists 19 establishments in Denmark whose registry records include ear, nose and throat: 9 with a channel role (importer, distributor, wholesaler or authorised representative), 5 registration holders without a channel role, and 5 registered as manufacturer or exporter only, out of 608 medical device establishments in Denmark overall. The records come from EUDAMED, US FDA (openFDA), 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 | 37% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 2 | 11% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 4 | 21% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 8 | 42% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 14 | 74% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 4 | 21% | 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 Denmark
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 19 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 | Ambu A/S Ballerup | Channel Importer, Distributor, Authorised representative, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +6 more | 84 | 28 | 0 | 60.0 | 4/5 |
| 2 | SBO Hearing A/S Smørum | Channel Authorised representative, Registration holder, Manufacturer | Ear, nose and throat | 152 | 7 | 0 | 52.2 | 4/5 |
| 3 | Auditdata A/S Copenhagen | Channel Distributor, Registration holder, Manufacturer, Exporter | Ear, nose and throat, Orthopaedics, spine and trauma | 12 | 8 | 0 | 43.9 | 4/5 |
| 4 | Oticon A/S Smørum | Channel Importer, Authorised representative, Manufacturer | Ear, nose and throat | 4 | 1 | 0 | 28.4 | 4/5 |
| 5 | Medidyne A/S Nærum | Channel Importer | Anaesthesia and respiratory, Cardiovascular, Ear, nose and throat +2 more | 0 | 0 | 18 | 24.3 | 4/5 |
| 6 | Kirstine Hardam A/S Holstebro | Channel Importer | General hospital and consumables, Ear, nose and throat, Gastroenterology, urology and OB/GYN | 0 | 0 | 12 | 22.9 | 4/5 |
| 7 | MEDshop.dk ODENSE NV | Channel Importer | Cardiovascular, Ear, nose and throat, In-vitro diagnostics +1 more | 0 | 0 | 5 | 19.9 | 4/5 |
| 8 | Argon Medical Devices Danmark ApS Ballerup | Channel Importer | Cardiovascular, General hospital and consumables, Ear, nose and throat +5 more | 0 | 0 | 1 | 15.7 | 4/5 |
| 9 | Friendship Europe ApS Roskilde | Channel Importer, Authorised representative | General hospital and consumables, Ear, nose and throat, Patient monitoring and neurology | 0 | 0 | 0 | 15.3 | 3/5 |
| 10 | Natus Medical Denmark ApS Taastrup | Holder Registration holder, Manufacturer | General hospital and consumables, Ear, nose and throat, Patient monitoring and neurology +2 more | 124 | 29 | 0 | 58.2 | 4/5 |
| 11 | Interacoustics A/S Middelfart | Holder Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Ear, nose and throat +1 more | 46 | 28 | 0 | 54.7 | 4/5 |
| 12 | GN Hearing A/S Ballerup | Holder Registration holder, Manufacturer | Ear, nose and throat | 27 | 16 | 0 | 48.0 | 4/5 |
| 13 | William Cook Europe ApS Bjaeverskov | Holder Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, Ear, nose and throat | 18 | 9 | 0 | 43.5 | 3/5 |
| 14 | Elos Medtech Pinol A/S Gørløse | Holder Registration holder, Manufacturer | Dental, Ear, nose and throat, Orthopaedics, spine and trauma | 34 | 4 | 0 | 43.3 | 4/5 |
| 15 | Sterigenics Denmark A/S Espergaerde Sjaelland | Manufacturer Manufacturer | Cardiovascular, General hospital and consumables, Dental +6 more | 50 | 1 | 0 | 32.9 | 3/5 |
| 16 | WS Audiology A/S Lynge Hovedstaden | Manufacturer Manufacturer | Ear, nose and throat | 3 | 1 | 0 | 20.0 | 3/5 |
| 17 | Oscilla A/S Aarhus | Manufacturer Manufacturer | Ear, nose and throat | 1 | 1 | 0 | 19.8 | 4/5 |
| 18 | LIZN APS Risskov Midtjylland | Manufacturer Manufacturer, Exporter | Ear, nose and throat | 1 | 1 | 0 | 18.7 | 3/5 |
| 19 | ASICOMO A/S Rodby Sjaelland | Manufacturer Manufacturer | Ear, nose and throat | 1 | 1 | 0 | 16.5 | 3/5 |
Questions about ear, nose and throat distributors in Denmark
How many ear, nose and throat distributors are there in Denmark?
The Index counts 19 establishments in Denmark 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 EUDAMED, US FDA (openFDA), Health Canada and web and was last refreshed on 22 October 2026.
Who can hold a ear, nose and throat device registration in Denmark?
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 Denmark?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Denmark 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 Denmark?
A company that appears in a public regulatory registry with an address in Denmark 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 Denmark
Ear, nose and throat in other EU and EEA markets
Sources
- EUDAMED economic operator registration, European Commission public API: 15 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 13 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 8 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
- web (public register): 5 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.