Certification

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

  • ISO Certificate

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



  • ce-cart-thumb

    The CE-mark indicates that MAICO Diagnostics GmbH meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. Approval is made by TÜV identification No. 0123.



  • mdsap-cert-thumb

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