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).



Find us on those events

  • eroc-2025-logo-for-website

    EROC 2025

    January 16-18, 2025
    Dubai, UAE

  • Introductory course in audiometry

    February 5, February 26, March 12, April 16, 2025
    Bremen/Hamburg, Dortmund, Munich, Leipzig

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