Updated 25 October 2026
IVD distributors in Hungary: 0 independent, 22 licensed firms
Hungary has 22 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 in vitro diagnostics, laboratory diagnostics and diagnostic reagent distributors in Hungary: the Index groups analysers, reagents, rapid tests and laboratory consumables in one segment.
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Distributor in Hungary? Add your company, free
Include manufacturers, their own sales entities and regulatory representatives (22)
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.
- 10 lines0 registrationsSize score 35 of 100
- 277 Elektronika Műszeripari KftBudapest0 lines0 registrationsSize score 34 of 100
- 30 lines0 registrationsSize score 33 of 100
- 40 lines0 registrationsSize score 28 of 100
- 50 lines0 registrationsSize score 24 of 100
- 6Biolab ZrtBudapest0 lines0 registrationsSize score 15 of 100
- 7Newmars Technologies kft.Budapest V0 lines0 registrationsSize score 15 of 100
- 83DHISTECH Kft.Budapest0 lines1 registrationSize score 34 of 100
- 9Diatron MI Plc.Budapest0 lines1 registrationSize score 27 of 100
- 1077 ELEKTRONIKA KFT.Budapest0 lines1 registrationSize score 22 of 100
- 11Diamond Diagnostics Inc.Budapest0 lines1 registrationSize score 41 of 100
- 12GREINER BIO-ONE HUNGARY KFTMosonmagyarovar Gyor-Moson-Sopron0 lines1 registrationSize score 18 of 100
- 13Clinichem Ltd.Budapest0 lines0 registrationsSize score 39 of 100
- 14Bioxol KftBudapest0 lines0 registrationsSize score 35 of 100
- 150 lines0 registrationsSize score 31 of 100
- 16Omixon Biocomputing Ltd.Budapest0 lines0 registrationsSize score 27 of 100
- 17APIRO Diagnostics Kft.Budaörs0 lines0 registrationsSize score 22 of 100
- 180 lines0 registrationsSize score 21 of 100
- 190 lines0 registrationsSize score 18 of 100
- 200 lines0 registrationsSize score 15 of 100
In-vitro diagnostics covers analysers, reagents, rapid tests and laboratory consumables across chemistry, haematology, microbiology, immunology and genetics. IVD has its own regulation in most markets, and the EU regulates it under IVDR rather than MDR. Laboratory distributors usually differ from device distributors, even inside the same company.
The Bastion Hale Distributor Index lists 22 establishments in Hungary whose registry records include in-vitro diagnostics: 0 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 15 manufacturers or exporters, out of 644 medical device establishments in Hungary overall. The records come from EUDAMED, US FDA (openFDA), MHRA UK and Health Canada, last seen on 23 October 2026.
Entry decision: in-vitro diagnostics in Hungary
CE marked: go now, rank 25 of 124. FDA cleared: not now, rank 91 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 IVD means unknown, not none.
FDA cleared, shipping from the US
Not now blocked for this maker today
Rank 91 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 IVD 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 in-vitro diagnostics, 234 in Hungary overall.
Makers registered here: 7 makers' own import or sales entities and 15 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: in-vitro diagnostics. 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 in-vitro diagnostics: about USD 75m to 110m 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 5.4m to 16m a year. SOM, what a new maker with one good distributor could win a year after about three years, is about USD 76k to 450k (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 | 7 | 32% | Named as importer: EUDAMED importer. |
| Registration holder | 1 | 5% | Holds device licences or registrations in its own name: Health Canada MDALL licence holder. |
| Manufacturer | 21 | 95% | Registered as a manufacturer with an address in this market: EUDAMED manufacturer; US FDA registered manufacturer; MHRA registered manufacturer; Health Canada licence as manufacturer. |
| Exporter | 2 | 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 IVD distributors in Hungary
How many IVD distributors are licensed in Hungary?
The Index counts 22 establishments in Hungary with in-vitro diagnostics 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, US FDA (openFDA), MHRA UK and Health Canada and was last refreshed on 25 October 2026.
Who distributes laboratory reagents and analysers in Hungary?
The Index counts laboratory reagents and analysers with the other in-vitro diagnostics. None of the 22 firms in Hungary with in-vitro diagnostics 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 an in-vitro diagnostics 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 an IVD 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 an IVD 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 in-vitro diagnostics 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 in-vitro diagnostics 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 in-vitro diagnostics market in Hungary?
Health spending in Hungary was USD 13.6bn in 2023 (World Bank). Bastion Hale estimates the in-vitro diagnostics market at about USD 75m to 110m 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
In-vitro diagnostics in other EU and EEA markets
Sources
- EUDAMED economic operator registration, European Commission public API: 17 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: 5 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 2 establishments, last seen 23 October 2026. Public register.
- 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.
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.