Updated 22 October 2026
Medical device distributors in Iceland: 35 licensed establishments
The Bastion Hale Distributor Index lists 35 medical device establishments registered with an address in Iceland: 23 with a channel role (importer, distributor, wholesaler or authorised representative), 1 registration holders without a channel role, and 11 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
| Segment | Establishments | |
|---|---|---|
| Surgery and endoscopy | 2 | Search in the Index |
| Orthopaedics, spine and trauma | 2 | Search in the Index |
| Cardiovascular | 1 | Search in the Index |
| Ear, nose and throat | 1 | Search in the Index |
| Anaesthesia and respiratory | 1 | Search in the Index |
| Patient monitoring and neurology | 5 | Search in the Index |
| General hospital and consumables | 2 | Search in the Index |
| No segment in the registry record | 29 |
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.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 23 | 66% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 1 | 3% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 1 | 3% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 3 | 9% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 14 | 40% | Registered as a manufacturer with an address in this market, including foreign registrations. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in Iceland
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 Next 10 Markets report 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 | Nox Medical Reykjavik | Channel Importer, Distributor, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, Ear, nose and throat +1 more | 18 | 10 | 0 | 46.8 | 4/5 |
| 2 | Kerecis Limited Isafjordur | Channel Importer, Authorised representative, Registration holder, Manufacturer | General hospital and consumables, Surgery and endoscopy | 12 | 3 | 0 | 40.1 | 4/5 |
| 3 | Adfong - Hagar verslanir Reykjavik | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 4 | Costco Wholesale Iceland ehf Garðabær | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 5 | Donna ehf Hafnarfjordur | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 6 | Fastus ehf Reykjavík | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 7 | Harmonix ehf. Hafnarfjordur | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 8 | Heilsa ehf. Kopavogur | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 9 | Icepharma hf. Reykjavík | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 10 | Inter ehf Reykjavík | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 11 | Kísill ehf. Kópavogur | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 12 | Landspitali University Hospital Reykjavík | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 13 | MEDOR Gardabaer | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 14 | Mobility ehf Garðabær | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 15 | Netkria ehf Hafnarfjordur | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 16 | Nova hf. Reykjavík | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 17 | Oral Medica ehf. Garðabær | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 18 | Ortopedia ehf Reykjavík | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 19 | Paramed Reykjavík | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
| 20 | Provision ltd. Reykjavík | Channel Importer | No segment in record | 0 | 0 | 0 | 9.7 | 2/5 |
Questions about medical device distributors in Iceland
How many medical device distributors are there in Iceland?
The Index counts 35 medical device establishments registered in Iceland, of which 23 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 Iceland?
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 Iceland?
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 Iceland to see the counts for your segment and reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a distributor in Iceland?
An establishment is a company that appears in a public regulatory registry with an address in Iceland, 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.
Related markets in EU and EEA
Sources
- EUDAMED economic operator registration, European Commission public API: 33 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: 6 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 3 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.