BEUDAMED
    Product Code: HIY FDA class 1 21 CFR 886.1090

    Brush, Haidinger, (Including Macular Integrity)

    Ophthalmic

    The Haidinger Brush (including Macular Integrity devices) is an ophthalmic instrument that uses polarized light to create an entoptic visual phenomenon, enabling clinicians to assess macular function and detect eccentric fixation. It is classified as FDA Class 1, the lowest risk category, governed by general controls only without requiring premarket notification. The product code is HIY, regulated under 21 CFR 886.1090, within the Ophthalmic medical specialty. No special risk flags apply to this device.

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    510(k)s
    0
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    HIY
    Device Class
    FDA class 1
    Regulation Number
    886.1090
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.