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.
MAICO Diagnostics GmbH is certified to the requirements of ISO 13485:2016.
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.
MAICO Diagnostics GmbH is certified to the requirements of the Medical Device Single Audit Program (MDSAP).
10393 West 70th St
Eden Prairie, MN 55344
Direct Number: (952) 941-4200
Toll Free: (888) 941-4201
Fax Number: (952) 903-4100
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