Buy Medical Equipment in Slovakia

A ŠÚKL notice within 14 days

In Slovakia, Act No. 362/2011 covers drugs and medical devices and sets national device rules alongside EU regulations. ŠÚKL, the state institute for drug control, is the authority for devices as well as medicines. Our quotes cover equipment, not the pharmaceutical life sciences. Whoever first makes a class IIa or higher device available on the Slovak market notifies ŠÚKL within 14 days, and ŠÚKL then assigns a ŠÚKL code. Since 28 May 2026, distributors must also register with ŠÚKL, whatever their seat. Units from Great Britain arrive as non-EU imports, so our Slovak quotes begin with the paperwork for these steps.

MediGear, the name we trade under, belongs to a medical equipment distributor registered in England and Wales. For hospitals and health systems in more than 80 countries, we handle everything from the first quote to the export papers and freight. For Slovakia, we look for verified manufacturers that can provide instructions in Slovak and product data for your ŠÚKL notice. Each point below is cleared before the quote goes to your biomedical engineers. Requests can go through the buyers page, and you will not need an account.

Slovakia hospitals: university, faculty and private groups

Healthcare in Slovakia is paid for through health insurers such as VšZP and Dôvera, and we quote for these buyers:

• Health care Bratislava: Univerzitná nemocnica Bratislava (University Hospital Bratislava) and its five sites
• Kosice hospitals such as Univerzitná nemocnica Louisa Pasteura (UNLP)
• The faculty hospitals in Žilina and Banská Bystrica, and Univerzitná nemocnica Martin (Martin University Hospital)
• Private groups such as Penta Hospitals and AGEL, and breast imaging centres
• Vets and dentists running X-ray units
• Defence ministry health services
• A wholesale distributor registered with ŠÚKL

Public procurement follows Act No. 343/2015, and the EKS electronic contracting system includes an e-marketplace for standard goods—the new Univerzitná nemocnica sv. Martina reached shell stage in July 2026, with full fit-out due by the end of 2028 and patients expected in 2029. In Banská Bystrica, fit-out of the new hospital is planned to run until November 2028. Both new hospitals will need equipment as their healthcare capacity takes shape. A single unit for a private clinic is quoted on the same terms.

ŠÚKL codes, distributor numbers and Slovak labels

Since 28 May 2026, manufacturers, importers and authorised representatives register in EUDAMED, while the notice of first making available stays with ŠÚKL and distributors now have to register nationally too. The notice of first making available brings a ŠÚKL code, and a device that already has one need not be notified again. Distributors register before they notify, receive a DIS number valid for five years and appear on a list that ŠÚKL updates daily.

Labels may be in English only for devices not meant for patient use, and only with instructions for use in Slovak. ŠÚKL inspectors check both texts on the market. Medical device registration in Slovakia has an EU part (EUDAMED) and a national part (ŠÚKL), and neither is ours to file. Our quotes list the unit's certificates, but they do not include regulatory advice.

Slovakia X-ray apparatus: ÚVZ permits, acceptance and stability tests

Radiation protection falls to ÚVZ SR, the Public Health Authority, under Act No. 87/2018. It permits activities that lead to exposure and also permits the distribution, sale, and lease of radiation sources, as well as their import from third countries. Under the 2018 decree on medical exposure, the supplier arranges the acceptance test of a unit, unless the provider procures the equipment itself. Only a holder of a test permit may carry it out.

A unit that fails may be used only after repair and a new test, and a unit out of clinical use for more than two years needs a fresh acceptance test. Long-term stability tests then follow every 6 months for CT, mammography and DSA. They follow every 12 months for radiography, fluoroscopy, mobile, panoramic and CBCT units, and every 24 months for intraoral dental and veterinary X-ray. Shielding is tested every 36 months, and the provider runs its own constancy tests.

230 V, Slovak IFU and stability tests

Most of these characteristics of medical devices in Slovakia are settled with the maker before we quote, and the rest with you:

• Mains and plug. Slovakia runs on 230 V at 50 Hz, and the IEC tables list type C, so we check the plug and power module.
• Slovak instructions. An English label is allowed only for devices not used by patients and only with Slovak instructions, so we check what the manufacturer can supply.
• Acceptance test. We agree with you that the acceptance test is arranged through a test-permit holder, and spare parts and consumables can ship with the unit.
• Unit history. For a pre-owned unit, the quote states when it was last in clinical use, since more than two years idle means a new acceptance test.

Open points go to the manufacturer in writing before the quote, because the ŠÚKL notice and the acceptance test both refer to the exact unit.

eDovoz declarations, EU representatives and ÚKSÚP checks

The Financial Administration takes import declarations electronically, through eDovoz, with paper only in a contingency, and customs recommends using specialist firms. Every Slovak consignment comes with:

• The invoice that sets the customs value, with a packing list
• Transport documents for each leg
• Origin proof for the declaration
• HS codes listed per item
• The CE file and the Slovak IFU

ÚKSÚP, the plant protection body, checks wood packaging at the first point of entry into the EU or at control points, and looks for the ISPM 15 mark. Wood from the UK needs that mark too, so we ask manufacturers for heat-treated, stamped crates.

Hamburg, Koper, METRANS terminals and Bratislava airport

1. Request and notice. Send the model, quantity and site by RFQ form or email, and say whether the device already has a ŠÚKL code.
2. Quote with Slovak texts. As a rule, catalogue items get a quote within 48 hours that covers certification, lead time, the route and the Slovak texts.
3. Signed approval. Your signed approval of the quote, by email or letter, starts the order.
4. Sea port and rail. Sea freight arrives at Hamburg, Bremerhaven, Rotterdam, Koper, or Gdańsk and moves by rail to METRANS terminals in Dunajská Streda, Košice, or Žilina. In contrast, air freight arrives at Bratislava airport's cargo unit.

We hand over at the port, rail terminal or airport you nominate, and your declarant files the import declaration electronically from there. Onward transport to site is yours, and the Danube ports in Bratislava, Komárno and Štúrovo can take river cargo.

Single units, new wards and refurbished units

Most catalogue lines are quoted per unit, so a practice in Žilina can ask for one ultrasound machine, and so can hospitals Slovakia-wide. New wards can start from hospital setup, and heart teams can browse Cardiology Equipment. Our refurbished range can serve Slovakia, since no national ban on used or refurbished devices turned up in ŠÚKL's guidance. ŠÚKL treats whoever fully refurbishes a device as its manufacturer, and the Slovak IFU, the 14-day notice and the acceptance test apply to used units too.

Disclaimer

General information for Slovak buyers is all this page offers. Please do not treat it as an offer to supply or as legal, regulatory or customs advice. What we quote reflects the manufacturer's stock, and an order is fixed only when both sides agree in writing. Devices need a Slovak IFU and the ŠÚKL notice, and X-ray units need ÚVZ permits and an acceptance test. Clearance, the ŠÚKL steps and the ÚVZ permits stay with you and your declarant, as we are neither importer nor distributor in Slovakia.