Updated 25 October 2026
Urology device distributors in Greece: 0 independent, 10 licensed firms
Greece has 10 licensed establishments in the Index and no independent distributor yet. EUDAMED does not list distributors, so the Index cannot see them here yet. The real number is higher than zero.
This page covers urology, gastroenterology and dialysis distributors in Greece: the Index groups endoscopy accessories, lithotripsy, dialysis, urology catheters and women's health devices in one segment.
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Include manufacturers, their own sales entities and regulatory representatives (10)
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.
- 1DOCTUM PHARMACEUTICAL SA K.GIOKARIS & CoPeania Attikis0 lines0 registrationsSize score 30 of 100
- 2VITROMED SMPCIlion Attiki0 lines1 registrationSize score 18 of 100
- 30 lines0 registrationsSize score 27 of 100
- 4ΠΡΟΜΗΦΑΡ Ο.Ε.Athens0 lines0 registrationsSize score 23 of 100
- 50 lines0 registrationsSize score 13 of 100
- 60 lines0 registrationsSize score 18 of 100
- 7BOURNAS MEDICALSAthens0 lines0 registrationsSize score 45 of 100
- 80 lines0 registrationsSize score 32 of 100
- 9FREZYDERM A.B.E.E.Αθήνα0 lines0 registrationsSize score 27 of 100
- 100 lines0 registrationsSize score 24 of 100
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 10 establishments in Greece whose registry records include gastroenterology, urology and ob/gyn: 0 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 2 manufacturers' own import or sales entities, 0 regulatory representatives, and 8 manufacturers or exporters, out of 482 medical device establishments in Greece overall. The records come from EUDAMED and US FDA (openFDA), last seen on 23 October 2026.
Entry decision: gastroenterology, urology and ob/gyn in Greece
CE marked: go now, rank 21 of 124. FDA cleared: not now, rank 85 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 21 of 124 markets for this maker.
Your CE marking is the market authorisation; foreign makers sell through distributors here; health spending of USD 20.4bn (2023, World Bank); distributor numbers not countable here because EUDAMED does not list distributors.
Medium confidence: EUDAMED does not list distributors, so a zero for gastroenterology and urology means unknown, not none.
FDA cleared, shipping from the US
Not now blocked for this maker today
Rank 85 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 a zero for gastroenterology and urology means unknown, not none.
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. Firms are required to work with local partners or set up a branch to navigate EU and local rules and tenders.
US Commercial Service country guide, published 4 September 2025.
Independent distributors in the Index: 0 for gastroenterology, urology and ob/gyn, 253 in Greece overall.
Makers registered here: 2 makers' own import or sales entities and 8 manufacturers.
Landed cost
Landed cost from the EU: no duty or import tax collected at the border (same customs area).
Landed cost from the US: about 24% collected at the border, under 1% real after credits (high confidence, from published tariff and tax rates). No duty, import VAT or GST about 24%.
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 918, MFN applied, HS6, Your Europe: VAT rates applied in EU member countries (last checked 13/07/2026).
Market size
Health spending: USD 20.4bn in 2023, USD 1,963 per person (World Bank).
Whole market (TAM) for gastroenterology, urology and OB/GYN: about USD 47m to 120m 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 3.7m to 15m a year. SOM, what a new maker with one good distributor could win a year after about three years, is about USD 55k to 390k (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 473 establishments, the 249 independent distributors first. Company records only. 9 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 | 2 | 20% | Named as importer: EUDAMED importer. |
| Manufacturer | 10 | 100% | Registered as a manufacturer with an address in this market: EUDAMED manufacturer; US FDA registered manufacturer. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in Greece
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 Greece: 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 Greece
How many urology and gastroenterology distributors are licensed in Greece?
The Index counts 10 establishments in Greece with gastroenterology, urology and ob/gyn in their registry record, of which 0 are independent distributors (a channel role and no manufacturing of their own). EUDAMED does not list distributors, so the Index cannot see them here yet. The real number is higher than zero. The number comes from EUDAMED and US FDA (openFDA) and was last refreshed on 25 October 2026.
Who distributes dialysis and urology products in Greece?
The Index counts dialysis and urology products with the other gastroenterology, urology or OB/GYN devices. None of the 10 firms in Greece with gastroenterology, urology or OB/GYN devices on record is an independent distributor in the registries yet. EUDAMED does not list distributors, so the Index cannot see them here yet. The real number is higher than zero.
Who can hold a gastroenterology, urology and ob/gyn device registration in Greece?
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 Greece?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Greece 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 Greece?
A company that appears in a public regulatory registry with an address in Greece 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 Greece?
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 Greece?
Health spending in Greece was USD 20.4bn in 2023 (World Bank). Bastion Hale estimates the gastroenterology, urology and ob/gyn market at about USD 47m to 120m 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 Greece
Gastroenterology, urology and OB/GYN in other EU and EEA markets
Sources
- EUDAMED economic operator registration, European Commission public API: 9 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: 1 establishment, last seen 22 October 2026. US government work, public domain.
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.