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  • Certificate No. 60143811

    • Certificate Number
      HD 60143811
    • Certificate Holder
      Fischer ANalysen
      Instrumente GmbH
      Brahestr. 25-27
      04347 Leipzig
    • Scope

      Aspects of manufacture concerned with the conformity of
      medical devices for respiratory gas analysis
      with the metrological requirements
      Replaces Approval, Registration No. HD 60108528 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.