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  • Certificate No. 60148245

    • Certificate Number
      HD 60148245
    • Certificate Holder
      Cardiomatics Sp. z o.o.

      ul. Wojciecha Weissa 7/C1
      31-339 Kraków
      Poland
    • Scope

      Standalone software for ECG signal analysis
      Replaces EC Certificate, Registration No.: HD 60129514 0001

    • Fulfilled Standards
      Richtlinie 93/42/EWG
    • Certificate Type
      Vollst. QMS, Anhang II MDD

      EC declaration of conformity (Full quality assurance system)
      Certificate according to Annex II Section 3 of the EC Directive 93/42/EEC concerning Medical Devices

      The Notified Body hereby certifies the application of the quality system by the manufacturer approved for the design, manufacture and final inspection of the products concerned, as specified in Annex II, Section 3 of the EC directive 93/42/EEC.

      The manufacturer is subject to audit as laid down in Sections 3.3 and 4 and to Community surveillance as specified in Section 5.

      This approval can be used by the company in line with the declaration of conformity.