System and procedure pack producers in Sweden
Look up medical device manufacturers, authorised representatives, importers, and system producers registered across the EU.
A system or procedure pack producer combines CE-marked devices into a single offering.
29 System and procedure pack producers in Sweden registered in EUDAMED
Role and obligations in EUDAMED
A producer of systems or procedure packs combines CE-marked devices to place a system or procedure pack on the market under the conditions of Article 22 of the MDR (2017/745).
Medical device companies in Sweden
Top locations in Sweden: Stockholm, Solna, Lund, Göteborg, Uppsala.
Frequently asked questions
What is a system or procedure pack producer?
A producer combines CE-marked devices into a system or procedure pack placed on the market under Article 22 of the MDR (2017/745).
Do system and procedure pack producers register in EUDAMED?
Yes. They register as economic operators in EUDAMED for the systems and procedure packs they place on the market.
Do the combined devices keep their own CE marking?
The individual devices retain their CE marking; the producer issues a statement for the combination under Article 22.