Updated 23 October 2026
Imaging and radiology equipment distributors in Norway: 10 licensed establishments
EUDAMED does not list distributors, so the Index only sees the 1 independent distributor tagged imaging, radiology and radiotherapy that appear as importers or in other registries. The real number is higher.
The Bastion Hale Distributor Index lists 10 establishments in Norway whose registry records include imaging, radiology and radiotherapy: 1 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 7 manufacturers' own import or sales entities, 0 regulatory representatives, and 2 manufacturers or exporters, out of 254 medical device establishments in Norway overall. The records come from EUDAMED, US FDA (openFDA), Health Canada and MHRA UK, last seen on 23 October 2026.
Entry decision: imaging, radiology and radiotherapy (RADI) in Norway
For a typical maker, from public data and the free Market Finder. Your own clearance, device class and current markets change the answer.
CE marked, shipping from the EU
Go now Rank 12 of 112 markets for this maker.
Your CE marking is the market authorisation; foreign makers sell through distributors here; health spending of USD 45.8bn (2023, World Bank); distributor numbers not countable here because EUDAMED does not list distributors (1 seen in RADI so far).
Medium confidence: EUDAMED does not list distributors, so the count seen in RADI (1) is a minimum.
FDA cleared, shipping from the US
Not now Rank 59 of 112 markets for this maker.
Held back: CE marking needed first; FDA clearance alone is not accepted here.
Medium confidence: EUDAMED does not list distributors, so the count seen in RADI (1) is a minimum.
Registration route
With CE marking: Your CE marking is the market authorisation. High confidence.
With FDA clearance: CE marking needed first; FDA clearance alone is not accepted here. High confidence.
No local holder is needed for a maker based inside this regulatory area. Who holds the registration
CE marking under the MDR is the market authorisation; no national approval. A non-EU maker needs an EU authorised representative.
Timeline and fees are not shown: no official source we cite gives them for this market yet. Confirm with a regulatory specialist before you plan a launch date. Sources: Regulation (EU) 2017/745 on medical devices (MDR), EUR-Lex.
Sales channel
Distributor-led: Foreign makers sell through distributors here. The most common way of doing business is through agents and distributors.
US Commercial Service country guide, published 29 May 2026.
Independent distributors in the Index: 1 for imaging, radiology and radiotherapy, 65 in Norway overall.
Makers registered here: 7 makers' own import or sales entities and 2 manufacturers.
Landed cost
Landed cost from the EU: about 25% collected at the border, under 1% real after credits (high confidence, from published tariff and tax rates). No duty, import VAT or GST about 25%.
Landed cost from the US: about 25% collected at the border, under 1% real after credits (high confidence, from published tariff and tax rates). No duty, import VAT or GST about 25%.
Tariff basket: imaging, radiology and radiotherapy. Cash is collected at clearance. Real cost is what stays after a registered distributor recovers VAT and charges. Sources: World Bank WITS TRAINS tariff API, reporter 578, MFN applied, HS6, Norwegian Customs: Import guide for beginners.
Market size
Health spending: USD 45.8bn in 2023, USD 8,296 per person (World Bank).
Imaging, radiology and radiotherapy (TAM): about USD 270m to 410m a year (estimate, low confidence).
For one product line sold through distributors: SAM about USD 19m to 59m, SOM about USD 270k to 1.6m a year (estimate). The free Market Finder sizes your own product range.
Broad scope, as in MedTech Europe figures: devices, diagnostics and consumables at manufacturer prices. Narrower published figures are lower.
How we estimate. At manufacturer prices.
Next step
The finder ranks every market for your own device, clearance and current markets. The CSV lists 251 establishments, the 64 independent distributors first. Company records only. 3 rows are not in the CSV and stay on their profile pages, for example names of a person or records whose only source is the Health Canada licence list.
Listed
Independent distributors in the Index here, ranked by the lines each distributor carries, then registrations, then size.
- 1Vingmed ASAsker22 lines0 registrationssize 21.6
Include manufacturers, their own sales entities and regulatory representatives (9)
Manufacturers, companies that are a manufacturer's own import or sales arm, and regulatory representatives (authorised representatives, sponsors or registration holders with no import or distribution role). They are registered here but are not independent distributors.
- 1LAERDAL MEDICAL A/SStavanger3 lines18 registrationssize 60.4
- 20 lines15 registrationssize 59.2
- 3Ferno Norden Group ASSkoppum0 lines0 registrationssize 11.9
- 4GE Healthcare ASOslo0 lines0 registrationssize 9.7
- 50 lines0 registrationssize 9.7
- 6PHILIPS Norge ASOslo0 lines0 registrationssize 9.7
- 70 lines0 registrationssize 9.7
- 8NordicNeuroLab ASBergen0 lines5 registrationssize 37.9
- 9Medistim ASAOslo0 lines4 registrationssize 37.7
The Next 10 Markets report does not cover imaging, radiology or radiotherapy devices. The Index and Market Watch stay free.
See Germany: 880 independent distributors
Distributor in Norway? Add your company, free
Imaging, radiology and radiotherapy covers X-ray, ultrasound, CT, MRI, nuclear medicine and treatment systems. The Index lists these establishments because the registries contain them.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 8 | 80% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Registration holder | 4 | 40% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 5 | 50% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 1 | 10% | 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 Norway
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 register separately in EUDAMED. Distributors do not register there, which is why the Index lists few EU distributors. Neither owns the CE file, so 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.
Questions about imaging, radiology and radiotherapy distributors in Norway
How many imaging, radiology and radiotherapy distributors are there in Norway?
The Index counts 10 establishments in Norway with imaging, radiology and radiotherapy in their registry record, of which 1 are independent distributors (a channel role and no manufacturing of their own). EUDAMED does not list distributors, so the Index only sees the 1 independent distributor tagged imaging, radiology and radiotherapy that appear as importers or in other registries. The real number is higher. The number comes from EUDAMED, US FDA (openFDA), Health Canada and MHRA UK and was last refreshed on 23 October 2026.
Who can hold an imaging, radiology and radiotherapy device registration in Norway?
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 register separately in EUDAMED. Distributors do not register there, which is why the Index lists few EU distributors. Neither owns the CE file, so EU channel changes are easier than elsewhere.
How do I find an imaging, radiology and radiotherapy distributor in Norway?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Norway to see the names, free, no sign-up. The Next 10 Markets report does not cover imaging, radiology or radiotherapy devices.
What does the Distributor Index count as an imaging, radiology and radiotherapy distributor in Norway?
A company that appears in a public regulatory registry with an address in Norway and whose linked device listings fall in the imaging, radiology and radiotherapy segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
How are CE-marked and FDA-cleared imaging, radiology and radiotherapy devices registered in Norway?
With CE marking: your CE marking is the market authorisation. With FDA clearance: CE marking needed first; FDA clearance alone is not accepted here. No local holder is needed for a maker based inside this regulatory area. CE marking under the MDR is the market authorisation; no national approval. A non-EU maker needs an EU authorised representative. Confirm with a regulatory specialist before you plan a launch date.
How big is the imaging, radiology and radiotherapy market in Norway?
Health spending in Norway was USD 45.8bn in 2023 (World Bank). Bastion Hale estimates the imaging, radiology and radiotherapy market at about USD 270m to 410m a year at manufacturer prices. This is a model estimate with low confidence: health spending times the device share of health spending times the segment's share of world medical technology spending. The methodology page shows every input and source.
Other segments in Norway
Imaging, radiology and radiotherapy in other EU and EEA markets
Sources
- EUDAMED economic operator registration, European Commission public API: 10 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: 4 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 4 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 4 establishments, last seen 23 October 2026. Public register.
- Company website (the establishment's own public site): 7 establishments, last seen 23 October 2026. Enrichment, not a registry: segments and principals read from the company's own website.
Index build 23 October 2026. Each establishment is counted once per country after resolving names across sources. Company records only, as the registries publish them.
Registry data. Bastion Hale does not vouch for any establishment.