Updated 25 October 2026
Urology device distributors in Hungary: 0 independent, 11 licensed firms
Hungary has 11 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 Hungary: 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 (11)
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.
- 1Urosystem Zrt.Budapest0 lines1 registrationSize score 22 of 100
- 20 lines1 registrationSize score 21 of 100
- 3MEDRES MEDICAL ENGINEERING LTD.Biatorbagy Pest0 lines1 registrationSize score 18 of 100
- 4Pharmico Medical Kft.Debrecen Hajdu-Bihar0 lines1 registrationSize score 16 of 100
- 50 lines0 registrationsSize score 28 of 100
- 60 lines0 registrationsSize score 13 of 100
- 70 lines0 registrationsSize score 42 of 100
- 8Coloplast Hungary, KFTTatabanya Komarom-Esztergom0 lines3 registrationsSize score 36 of 100
- 9SUBAN Instruments Hungary Co.Debrecen Hajdu-Bihar0 lines1 registrationSize score 35 of 100
- 10MAM Hungária Kft.Vaskeresztes0 lines1 registrationSize score 24 of 100
- 110 lines0 registrationsSize score 27 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 11 establishments in Hungary 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), 1 manufacturer's own import or sales entity, 0 regulatory representatives, and 10 manufacturers or exporters, out of 644 medical device establishments in Hungary overall. The records come from US FDA (openFDA) and EUDAMED, last seen on 23 October 2026.
Entry decision: gastroenterology, urology and ob/gyn in Hungary
CE marked: go now, rank 25 of 124. FDA cleared: not now, rank 88 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 25 of 124 markets for this maker.
Your CE marking is the market authorisation; foreign makers sell through distributors here; health spending of USD 13.6bn (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 88 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. Foreign producers are advised to contract a local importer; only large multinationals run subsidiaries.
US Commercial Service country guide, published 12 February 2026.
Independent distributors in the Index: 0 for gastroenterology, urology and ob/gyn, 234 in Hungary overall.
Makers registered here: 1 maker's own import or sales entity and 10 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 27% collected at the border, under 1% real after credits (high confidence, from published tariff and tax rates). No duty, import VAT or GST about 27%.
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 13.6bn in 2023, USD 1,420 per person (World Bank).
Whole market (TAM) for gastroenterology, urology and OB/GYN: about USD 32m to 78m 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 2.5m to 9.8m a year. SOM, what a new maker with one good distributor could win a year after about three years, is about USD 37k to 260k (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 639 establishments, the 234 independent distributors first. Company records only. 5 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 | 1 | 9% | Named as importer: EUDAMED importer. |
| Manufacturer | 11 | 100% | Registered as a manufacturer with an address in this market: US FDA registered manufacturer; EUDAMED 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 Hungary
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 Hungary: 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 Hungary
How many urology and gastroenterology distributors are licensed in Hungary?
The Index counts 11 establishments in Hungary 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 US FDA (openFDA) and EUDAMED and was last refreshed on 25 October 2026.
Who distributes dialysis and urology products in Hungary?
The Index counts dialysis and urology products with the other gastroenterology, urology or OB/GYN devices. None of the 11 firms in Hungary 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 Hungary?
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 Hungary?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Hungary 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 Hungary?
A company that appears in a public regulatory registry with an address in Hungary 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 Hungary?
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 Hungary?
Health spending in Hungary was USD 13.6bn in 2023 (World Bank). Bastion Hale estimates the gastroenterology, urology and ob/gyn market at about USD 32m to 78m 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 Hungary
Gastroenterology, urology and OB/GYN in other EU and EEA markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 7 establishments, last seen 23 October 2026. US government work, public domain.
- EUDAMED economic operator registration, European Commission public API: 5 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
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.