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    Agfa NV - MDR EC Certificate

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    isaev.dilshat

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    © All Rights Reserved
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    Agfa NV - MDR EC Certificate

    Uploaded by

    isaev.dilshat
    21 views2 pages

    Original Title

    Agfa_NV_-_MDR_EC_Certificate

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    21 views2 pages

    Agfa NV - MDR EC Certificate

    Uploaded by

    isaev.dilshat

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    © All Rights Reserved
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    of 2

    Certificate Number:

    28620125060
    QUALITY MANAGEMENT SYSTEM CERTIFICATE
    Revision:
    EU Regulation 2017/745 for Medical Devices, 01

    Annex IX Chapters I & III Initial Certification Date:


    21 June 2022

    We hereby declare that a conformity assessment based on a quality management Date of Certification Decision:
    system and technical documentation has been carried out following the 14 September 2023
    requirements of EU Regulation 2017/745 for Medical Devices.
    Certificate Issue Date:
    We certify that the documentation conforms to the relevant provisions of the 14 September 2023
    aforementioned regulation, and the result entitles the organization to use the CE
    2862 marking on the products listed below. Certificate Expiry Date:
    31 May 2027

    Agfa NV
    Septestraat 27, BE-2640 Mortsel, Belgium

    Manufacturer SRN: BE-MF-000000571

    Scope:
    Brian Mather
    - Imaging devices utilizing ionizing radiation for general, static and dynamic Certification Authority, MDR
    radiography Intertek Medical Notified Body AB,
    Torshamnsgatan 43,
    - Software for X-Ray systems Box 1103, SE-164 22 Kista, Sweden

    Intertek Medical Notified Body AB is a Notified Body in


    accordance with the requirements set out in EU Regulation
    2017/745 on medical devices, with the identification number
    2862.

    1 certificate, Intertek assumes no liability to any party other than to the Client, and then only in accordance with the agreed upon Certification
    In the issuance of this
    Agreement. This certificate’s validity is subject to the organisation maintaining their system in accordance with Intertek’s requirements for systems certification. Validity may
    be confirmed via email at [email protected] or by scanning the code to the right with a smartphone. The certificate remains the property of Intertek, to
    whom it must be returned upon request

    Page 1/2
    PRODUCT LIST FOR CERTIFICATE
    See attached Product List

    EXAMINATION AND TESTS PERFORMED


    Technical Assessment Report Reference TD0004-01 Agfa NV, DR800 Certificate Number:
    28620125060
    Audit Report Reference N/A Revision:
    01

    Initial Certification Date:


    21 June 2022
    CONDITIONS FOR OR LIMITATIONS TO VALIDITY OF CERTIFICATE
    Date of Certification Decision:
    14 September 2023
    None
    Certificate Issue Date:
    14 September 2023

    Certificate Expiry Date:


    31 May 2027

    Brian Mather
    Certification Authority, MDR
    CERTIFICATE HISTORY Intertek Medical Notified Body AB,
    Torshamnsgatan 43,
    PRECEDING CERTIFICATE DATE OF ISSUE IDENTIFICATION OF CHANGES Box 1103, SE-164 22 Kista, Sweden
    NUMBER
    28620125060 21 June 2022 Initial certificate Intertek Medical Notified Body AB is a Notified Body in
    accordance with the requirements set out in EU Regulation
    2017/745 on medical devices, with the identification number
    2862.

    In the issuance of this certificate, Intertek assumes no liability to any party other than to the Client, and then only in accordance with the agreed upon Certification
    Agreement. This certificate’s validity is subject to the organisation maintaining their system in accordance with Intertek’s requirements for systems certification. Validity may
    be confirmed via email at [email protected] or by scanning the code to the right with a smartphone. The certificate remains the property of Intertek, to
    whom it must be returned upon request

    Page 2/2

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