NB 0598

SGS FIMKO OY

Finland Active MDR IVDR
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About

SGS Fimko Oy is a European Union Notified Body (NB 0598) designated for both MDR and IVDR conformity assessment, based in Helsinki, Finland.

As part of the SGS Group, SGS Fimko Oy provides comprehensive conformity assessment services for medical device manufacturers. Their key competence areas include active devices, including Software as a Medical Device (SaMD) and Artificial Intelligence (AI)-based medical devices.

For MDR information, visit: SGS CE Marking of Medical Devices

Contact

Designation Details

NB Number0598
StatusActive
Regulation Scope
MDR IVDR

Contact Information

CountryFinland
AddressTakomotie 8, 00380 HELSINKI
Phone+358 9 696 361

Need Conformity Assessment?

Contact this Notified Body for MDR/IVDR device certification.

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