Updated 25 October 2026

X-ray and imaging distributors in Czechia: 0 independent, 12 licensed firms

Czechia has 12 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 X-ray, radiology equipment, ultrasound and medical imaging distributors in Czechia: the Index groups X-ray, ultrasound, CT, MRI, nuclear medicine and radiotherapy systems in one segment.

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Include manufacturers, their own sales entities and regulatory representatives (12)

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.

  1. 1
    MEDORO s.r.o.Pardubice
    0 lines0 registrationsSize score 18 of 100
  2. 2
    OR-CZ spol. s r.o.Moravská Třebová
    0 lines0 registrationsSize score 18 of 100
  3. 3
    0 lines1 registrationSize score 27 of 100
  4. 4
    0 lines0 registrationsSize score 17 of 100
  5. 5
    0 lines0 registrationsSize score 13 of 100
  6. 6
    0 lines0 registrationsSize score 13 of 100
  7. 7
    0 lines0 registrationsSize score 13 of 100
  8. 8
    0 lines0 registrationsSize score 34 of 100
  9. 9
    STERIS AST CZ s.r.o.Velka Bites Vysocina
    0 lines1 registrationSize score 34 of 100
  10. 10
    NOVANTA MEDICAL S.R.O.Prelouc Pardubicky Kraj
    0 lines1 registrationSize score 30 of 100
  11. 11
    0 lines0 registrationsSize score 42 of 100
  12. 12
    0 lines0 registrationsSize score 34 of 100

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.

The Bastion Hale Distributor Index lists 12 establishments in Czechia whose registry records include imaging, radiology and radiotherapy: 0 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 3 manufacturers' own import or sales entities, 0 regulatory representatives, and 9 manufacturers or exporters, out of 868 medical device establishments in Czechia overall. The records come from EUDAMED and US FDA (openFDA), last seen on 23 October 2026.

Entry decision: imaging, radiology and radiotherapy in Czechia

CE marked: go now, rank 19 of 124. FDA cleared: not now, rank 78 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 19 of 124 markets for this maker.

Your CE marking is the market authorisation; foreign makers sell through distributors here; health spending of USD 29.4bn (2024, World Bank); distributor numbers not countable here because EUDAMED does not list distributors.

Medium confidence: EUDAMED does not list distributors, so a zero for imaging means unknown, not none.

FDA cleared, shipping from the US

Not now blocked for this maker today

Rank 78 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 imaging 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. Developed European style distribution system with professional agents and distributors in most segments.

US Commercial Service country guide, published 8 September 2023.

Independent distributors in the Index: 0 for imaging, radiology and radiotherapy, 340 in Czechia overall.

Makers registered here: 3 makers' own import or sales entities and 9 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 21% collected at the border, under 1% real after credits (high confidence, from published tariff and tax rates). No duty, import VAT or GST about 21%.

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 918, MFN applied, HS6, Your Europe: VAT rates applied in EU member countries (last checked 13/07/2026).

Market size

Health spending: USD 29.4bn in 2024, USD 2,693 per person (World Bank).

Whole market (TAM) for imaging, radiology and radiotherapy: about USD 170m 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 12m to 38m a year. SOM, what a new maker with one good distributor could win a year after about three years, is about USD 180k to 1.0m (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 841 establishments, the 332 independent distributors first. Company records only. 27 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

RoleEstablishmentsShareWhat it means
Importer325%Named as importer: EUDAMED importer.
Manufacturer12100%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 Czechia

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 Czechia: the list

This is the general rule, not legal advice. The registration clause in the first distributor contract decides who controls the market later.

Questions about X-ray and imaging distributors in Czechia

How many X-ray and radiology distributors are licensed in Czechia?

The Index counts 12 establishments in Czechia with imaging, radiology and radiotherapy 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 X-ray and ultrasound equipment in Czechia?

The Index counts X-ray and ultrasound equipment with the other imaging, radiology or radiotherapy devices. None of the 12 firms in Czechia with imaging, radiology or radiotherapy 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 an imaging, radiology and radiotherapy device registration in Czechia?

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 X-ray and imaging distributor in Czechia?

Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Czechia 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 X-ray and imaging distributor in Czechia?

A company that appears in a public regulatory registry with an address in Czechia 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 Czechia?

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 Czechia?

Health spending in Czechia was USD 29.4bn in 2024 (World Bank). Bastion Hale estimates the imaging, radiology and radiotherapy market at about USD 170m 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 Czechia

Medical device distributors in Czechia, all segments

Imaging, radiology and radiotherapy in other EU and EEA markets

X-ray and imaging distributors in every market

Sources

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.