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    Registration Certificates

    MDR certificate - Regulation (EU) 2017/745

    The product mediCAD from mediCAD Hectec GmbH is certified according to MDR risk class IIa, certified by mdc medical device certification GmbH.

    EN ISO 13485

    The Quality Management System of company mediCAD Hectec GmbH is certified according to EN ISO 13485, certified by mdc medical device certification GmbH.

    MDD certificate - Council Directive 93/42/EEC

    mediCAD® complies with the basic requirements of the Council Directive 93/42/EEC as provided by the Quality System and is approved as a Class 1 medical product in accordance with this directive, certified by mdc medical device certification GmbH.

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