Certification

As a manufacturer of medical equipment, MAICO is certified in terms of ISO 13485:2016, the Medical CE-Mark and the Medical Device Single Audit Program (MDSAP). You will find the corresponding documents below.

  • iso_13485_2021_maico

    MAICO Diagnostics GmbH is certified to the requirements of ISO 13485:2016.



  • MDR Certificate TÜV SÜD MAICO

    The CE-mark indicates that MAICO Diagnostics GmbH meets the requirements pursuant to Regulation (EU) 2017/745 on Medical Devices, Annex IX Chapters I and III. Approval is made by TÜV SÜD identification No. 0123.



  • maico_mdsap_certificate

    MAICO Diagnostics GmbH is certified to the requirements of the Medical Device Single Audit Program (MDSAP).



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