Medical device manufacturers in Slovakia

Look up medical device manufacturers, authorised representatives, importers, and system producers registered worldwide.

A manufacturer places a medical device on the EU market under its own name and is responsible for its conformity.

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97 Medical device manufacturers in Slovakia registered in EUDAMED

Role and obligations in EUDAMED

A manufacturer is the legal entity that develops a medical device and places it on the EU market under its own name, bearing primary responsibility for the device’s conformity (MDR 2017/745, Article 10).

Medical device companies in Slovakia

Top locations in Slovakia: Bratislava, Košice, Piešťany, Trnava, Prešov.

Competent authority in Slovakia

Medical devices placed on the market in Slovakia are overseen by its national competent authority for market surveillance: ŠÚKL.

Frequently asked questions

What is a medical device manufacturer?

A manufacturer is the legal entity responsible for placing a medical device on the EU market under its own name and ensuring it meets the requirements of the MDR (2017/745) or the IVDR — règlement (UE) 2017/746.

Do manufacturers have to register in EUDAMED?

Yes. Manufacturers obtain a Single Registration Number (SRN) and register their actor and device data in EUDAMED.

Where are these manufacturers based?

EUDAMED lists manufacturers registered worldwide; you can filter this list by country.