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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Auto Ref-Topographer HRKT-1

    DI: 08800019600992 · Model: HRKT-1 · Huvitz Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    2
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Auto Ref-Topographer HRKT-1
    Primary DI
    08800019600992
    Version / Model
    HRKT-1
    Company Name
    Huvitz Co., Ltd.
    Labeler DUNS
    688154202
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-30
    Public Version
    1
    Public Version Date
    2026-02-09
    Public Version Status
    New
    Public Device Record Key
    da16b88a-f5c6-48dc-a1ed-5771752b9b6b

    Device Description

    The Auto Ref-Topographer HRKT-1 measures the light reflected from the retina using an MLA (Micro Lens Array) to provide information on the refractive power of the eye, and measures the curvature of the cornea and its defects by measuring the size of the image reflected from the cornea and testing for dry eye.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MMQ Topographer, Corneal, Ac-Powered

    GMDN Terms

    Code Name
    18038 Corneal topography system
    36386 Automated ophthalmic refractometer

    Identifiers

    Type ID
    Primary 08800019600992