BEUDAMED
    Product Code: KYD FDA class 1 21 CFR 886.1800

    Strip, Schirmer

    Ophthalmic

    The Schirmer Strip is an ophthalmic diagnostic device consisting of a standardized strip of filter paper placed at the lower eyelid margin to measure tear production, used in the evaluation of dry eye syndrome and lacrimal gland function. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, with no premarket submission required. The product code is KYD, regulated under 21 CFR 886.1800, in the Ophthalmic medical specialty. No special flags apply to this device.

    View on FDA
    510(k)s
    3
    FEI Numbers
    25
    Registration Numbers
    25
    Unique Applicants
    3
    Years Active
    8

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    Basic Information

    Product Code
    KYD
    Device Class
    FDA class 1
    Regulation Number
    886.1800
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K911734 TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM
    K881515 TEAR VOLUME TESTS
    K832181 SNO STRIPS STERILE TEARFLOW TEST STRIP

    FEI Numbers

    This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.