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    DC - Ce - HbA1c Enzymatic

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    DC - Ce - HbA1c Enzymatic

    Uploaded by

    DŨNG VŨ
    13 views2 pages

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    DC.ce - HbA1c Enzymatic

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    13 views2 pages

    DC - Ce - HbA1c Enzymatic

    Uploaded by

    DŨNG VŨ

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    © All Rights Reserved
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    EU Declaration of Conformity

    Manufacturer: Wiener Laboratorios S.A.I.C


    Riobamba 2944
    2000 Rosario – Santa Fe
    Argentina

    This declaration is issued under the sole responsibility of the manufacturer

    EC Representative: MT Promedt Consulting GmbH


    Ernst-Heckel-Straße 7
    66386 St. Ingbert
    Germany

    Product: HbA1c enzymatic

    GMDN Code: 63151

    EDMA Code: 11 02 01 14 00

    Intended purpose: Enzymatic method for HbA1c determination in


    whole blood

    Classification: “Other IVD” Non List A/Non List B/Not for self-
    testing

    Conformity assessment route: IVDD Annex III


    We herewith declare that the above-mentioned product meets the provisions of
    the Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices.

    Standards Applied: See next page

    Start of CE Marking: September 2010

    Place, date of issue: Rosario, November 15th, 2022

    Signature: Viviana E. Cétola


    Technical Director
    Wiener Laboratorios S.A.I.C.
    1
    Rev 004
    Conformity is shown by compliance with the applicable requirements of the
    following documents:
    Reference & Date Title
    EN ISO 13485:2016 Medical devices - Quality management systems -
    Requirements for regulatory purposes
    EN ISO 14971:2012 Medical devices - Application of risk management to medical
    devices
    EN 13612:2012 Performance evaluation of in vitro diagnostic medical devices

    EN ISO 18153:2003 In vitro diagnostic medical devices - Measurement of quantities


    in biological samples - Metrological traceability of values for
    catalytic concentration of enzymes assigned to calibrators and
    control materials
    EN ISO 17511:2003 In vitro diagnostic medical devices - Measurement of quantities
    in biological samples - Metrological traceability of values
    assigned to calibrators and control materials
    EN ISO 15193:2009 In vitro diagnostic medical devices - Measurement of quantities
    in samples of biological origin - Requirements for content and
    presentation of reference measurement
    EN ISO 15194:2009 In vitro diagnostic medical devices - Measurement of quantities
    in samples of biological origin - Requirements for certified
    reference materials and the content of supporting
    documentation
    EN ISO 15195:2003 Laboratory medicine — Requirements for reference
    measurement laboratories
    EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in
    vitro diagnostic reagents
    EN ISO 18113-1:2011 In vitro diagnostic medical devices - Information supplied by the
    manufacturer (labelling) - Part 1: Terms, definitions, and general
    requirements
    EN ISO 18113-2:2011 Information supplied by the manufacturer (labeling) -- Part
    2: In vitro diagnostic reagents for professional use
    EN ISO 15223-1:2016 Medical devices - Symbols to be used with medical device
    labels, labelling and information to be supplied - Part 1:
    General requirements
    EN 62366:2008 Medical devices - Application of usability engineering to
    medical devices
    2

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