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  • 2 Alcon CR Certificat 2024 g1 020895 0393 Rev.00

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    Alcon Laboratories has implemented a full quality assurance system for the design, manufacture, and inspection of various ophthalmic products in compliance with the European Directive on Medical Devices. The quality assurance system was certified by TÜV SÜD Product Service GmbH as meeting the requirements of the Directive for devices in class IIa, IIb, or III, excluding requirements for class III devices regarding Annex II section 4. The certificate is valid from 2021 to 2024 and subjects Alcon's quality system to periodic surveillance.

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    2 Alcon Cr Certificat 2024 g1 020895 0393 Rev.00

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    Alcon Laboratories has implemented a full quality assurance system for the design, manufacture, and inspection of various ophthalmic products in compliance with the European Directive on Medical Devices. The quality assurance system was certified by TÜV SÜD Product Service GmbH as meeting the requirements of the Directive for devices in class IIa, IIb, or III, excluding requirements for class III devices regarding Annex II section 4. The certificate is valid from 2021 to 2024 and subjects Alcon's quality system to periodic surveillance.

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    37 views1 page

    2 Alcon CR Certificat 2024 g1 020895 0393 Rev.00

    Uploaded by

    Cyber Chrono
    Alcon Laboratories has implemented a full quality assurance system for the design, manufacture, and inspection of various ophthalmic products in compliance with the European Directive on Medical Devices. The quality assurance system was certified by TÜV SÜD Product Service GmbH as meeting the requirements of the Directive for devices in class IIa, IIb, or III, excluding requirements for class III devices regarding Annex II section 4. The certificate is valid from 2021 to 2024 and subjects Alcon's quality system to periodic surveillance.

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    of 1

    EC Certificate

    Full Quality Assurance System


    Directive 93/42/EEC on Medical Devices (MDD), Annex II excluding (4)
    (Devices in Class IIa, IIb or III)
    No. G1 020895 0393 Rev. 00

    Manufacturer: Alcon Laboratories, Inc.


    6201 South Freeway
    Fort Worth, TX 76134-2099
    USA

    Product Category(ies): Ophthalmic Implants, Irrigating Solutions,


    Viscoelastics, Ophthalmic Surgical Disposable
    Products, Ophthalmic Surgical Procedure Packs,
    Contact Lens Care Products, Ophthalmic Cutting
    Instruments, Cannulas, Cystitomes, Surgical Sponges
    and Sutures, Ophthalmic Solutions and Gels, Surgical
    Devices and Electrosurgical Products for Use in
    Ophthalmic Procedures (Cataract, Vitroretinal, Laser
    and Imaging), Wavefront Technology Equipment for
    Ophthalmic Diagnostics and Ophthalmic Devices for
    the Treatment of Chronic Disease of the Eyelid, Sterile
    Soft Contact Lenses for Correction of Refractive Error
    and/or for Use as Bandage Lenses (Soft Corrective
    Contact Lenses, Extended Wear / Therapeutic Contact
    Lenses; Silicone Hydrogel Soft Contact Lenses,
    Corrective; Non-Silicone Hydrogel Soft Contact Lenses,
    Corrective)

    The Certification Body of TÜV SÜD Product Service GmbH declares that the aforementioned
    manufacturer has implemented a quality assurance system for design, manufacture and final
    inspection of the respective devices / device categories in accordance with MDD Annex II.
    This quality assurance system conforms to the requirements of this Directive and is subject to
    periodical surveillance. For marketing of class III devices an additional Annex II (4) certificate is
    mandatory. All applicable requirements of the testing and certification regulation of TÜV SÜD Group
    have to be complied with. For details and certificate validity see: www.tuvsud.com/ps-cert?q=cert:G1
    020895 0393 Rev. 00

    Report No.: 713194570

    Valid from: 2021-02-05


    Valid until: 2024-05-26

    Date, 2021-02-05

    Christoph Dicks
    Head of Certification/Notified Body

    Page 1 of 1
    TÜV SÜD Product Service GmbH is Notified Body with identification no. 0123

    TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 Munich • Germany

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