Updated 25 October 2026
Urology device distributors in Norway: 5 independent, 11 licensed firms
EUDAMED does not list distributors, so the Index only sees the 5 independent distributors tagged gastroenterology, urology and ob/gyn that appear as importers or in other registries. The real number is higher.
This page covers urology, gastroenterology and dialysis distributors in Norway: the Index groups endoscopy accessories, lithotripsy, dialysis, urology catheters and women's health devices in one segment.
Listed
Independent distributors in the Index here, ranked by the lines each distributor carries, then registrations, then size.
- 13 lines0 registrationsSize score 17 of 100
- 20 lines0 registrationsSize score 10 of 100
- 322 lines0 registrationsSize score 22 of 100
- 422 lines0 registrationsSize score 22 of 100
- 50 lines0 registrationsSize score 10 of 100
Include manufacturers, their own sales entities and regulatory representatives (6)
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.
- 1Endomed ASOslo4 lines0 registrationsSize score 16 of 100
- 2OneMed ASSkedsmokorset1 line0 registrationsSize score 12 of 100
- 3Med-Kjemi ASAsker2 lines0 registrationsSize score 16 of 100
- 40 lines0 registrationsSize score 13 of 100
- 5Lifeness A/STromsø0 lines0 registrationsSize score 13 of 100
- 6LAERDAL MEDICAL A/SStavanger3 lines18 registrationsSize score 71 of 100
See Germany: 875 independent distributors
Distributor in Norway? Add your company, free
Gastroenterology, urology and obstetrics covers flexible endoscopy accessories, lithotripsy, dialysis, catheters and women's health devices. Dialysis consumables bring large recurring volumes and a few dominant players. The rest of the segment is spread across many mid-sized importers.
The Bastion Hale Distributor Index lists 11 establishments in Norway whose registry records include gastroenterology, urology and ob/gyn: 5 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 4 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: gastroenterology, urology and ob/gyn in Norway
CE marked: go now, rank 13 of 124. FDA cleared: not now, rank 77 of 124. Show the full entry analysis
For a typical maker, from public data and the free Market Finder. Your own clearance, device class and current markets change the answer. The verdicts, best first: go now (route, channel and market size all work), go next (open, with one thing to solve first), build the case (two things to solve, or a full local registration in a large market), not now (blocked for this maker today).
CE marked, shipping from the EU
Go now the registration route, the sales channel and the market size all work
Rank 13 of 124 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 (5 seen in gastroenterology and urology so far).
Medium confidence: EUDAMED does not list distributors, so the count seen in gastroenterology and urology (5) is a minimum.
FDA cleared, shipping from the US
Not now blocked for this maker today
Rank 77 of 124 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 gastroenterology and urology (5) 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: 5 for gastroenterology, urology and ob/gyn, 64 in Norway overall.
Makers registered here: 4 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: gastroenterology, urology and ob/gyn. 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).
Whole market (TAM) for gastroenterology, urology and OB/GYN: about USD 110m to 260m a year (estimate, low confidence). TAM is all yearly spending on these devices in the market.
For one product line sold through distributors: SAM, the part of that spending distributors can reach, is about USD 8.3m to 33m a year. SOM, what a new maker with one good distributor could win a year after about three years, is about USD 120k to 870k (estimates). 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 63 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.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 9 | 82% | Named as importer: EUDAMED importer; Health Canada establishment licence (MDEL) to import; US FDA initial importer. |
| Distributor | 1 | 9% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, ANVISA, SAHPRA and other licence lists). |
| Authorised representative | 1 | 9% | Represents a foreign manufacturer towards the regulator: EU authorised representative in EUDAMED. |
| Registration holder | 1 | 9% | Holds device licences or registrations in its own name: Health Canada MDALL licence holder. |
| Manufacturer | 3 | 27% | Registered as a manufacturer with an address in this market: EUDAMED manufacturer; Health Canada licence as manufacturer; US FDA registered manufacturer; MHRA registered manufacturer. |
| Exporter | 1 | 9% | Registered as an exporter of devices: US FDA registration 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.
Who holds medical device registrations in Norway: the list
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 who holds the registration in each of your ten markets.
Next steps
Questions about urology device distributors in Norway
How many urology and gastroenterology distributors are licensed in Norway?
The Index counts 11 establishments in Norway with gastroenterology, urology and ob/gyn in their registry record, of which 5 are independent distributors (a channel role and no manufacturing of their own). EUDAMED does not list distributors, so the Index only sees the 5 independent distributors tagged gastroenterology, urology and ob/gyn 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 25 October 2026.
Who distributes dialysis and urology products in Norway?
The Index counts dialysis and urology products with the other gastroenterology, urology or OB/GYN devices, so it does not list them separately. The highest ranked independent urology device distributors in Norway on this page are Quintet AS, Kebomed AS and Vingmed AS. Open a profile to see the makers each one represents.
Who can hold a gastroenterology, urology and ob/gyn 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 a urology device 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. For a ranked shortlist for your device, see the Next 10 Markets report.
What does the Distributor Index count as a urology device 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 gastroenterology, urology and ob/gyn 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 gastroenterology, urology and ob/gyn 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 gastroenterology, urology and ob/gyn market in Norway?
Health spending in Norway was USD 45.8bn in 2023 (World Bank). Bastion Hale estimates the gastroenterology, urology and ob/gyn market at about USD 110m to 260m 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
Gastroenterology, urology and OB/GYN in other EU and EEA markets
Sources
- EUDAMED economic operator registration, European Commission public API: 11 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: 1 establishment, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 1 establishment, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 1 establishment, last seen 23 October 2026. Public register.
- Company website (the establishment's own public site): 9 establishments, last seen 23 October 2026. Enrichment, not a registry: segments and principals read from the company's own website.
Index build 25 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.