Medical device manufacturers in Sweden

Look up medical device manufacturers, authorised representatives, importers, and system producers registered across the EU.

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

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627 Medical device manufacturers in Sweden 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 Sweden

Top locations in Sweden: Stockholm, Solna, Lund, Göteborg, Uppsala.

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 across the EU and EEA; you can filter this list by country.