Details of registered operators

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Operators in the medical devices sector under registration obligation must register either in the public European EUDAMED database or in the national CERE register. In the future, Fimea will make the details of operators registered in the CERE register publicly available in list format. This makes it easier for register users such as contracting entities to access information about the operators. Publishing the details of the operators registered in the national CERE register puts all operators in an equal position as operator details are also publicly available in the EUDAMED database.

Operators are divided into two registers as follows

Users can search the EUDAMED database for information about:

medical device manufacturers;
authorised representatives in Europe;
importers; and
procedure pack assemblers.Public EUDAMED

Public EUDAMED

Operator lists published from the CERE register contain:

operators that distribute devices to retailers, healthcare and social welfare operators and other professional users;
Finnish manufacturers of custom-made devices; and
health institutions that manufacture medical devices in-house.

Special considerations about the operator information published by Fimea:

Some operators in the distribution chain are not liable to submit a notification to Fimea.
Information in the CERE register is based on the register notifications submitted by the operators.
The information is updated on the first business day of each month.
The date of the listing is shown in the right upper-hand corner of the file.
Even if an operator has registered medical device information in the CERE register, the list may be incomplete due to the two-week processing time.
To make sure the information is up to date, please send an email to [email protected] or call the switchboard on 029 522 3341 (telephone switchboard, request information about the operator registrations of medical devices).

Downloadable files