BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA

    DI: 04571130283343 · Model: TRK-3 · TOPCON CORPORATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
    Primary DI
    04571130283343
    Version / Model
    TRK-3
    Company Name
    TOPCON CORPORATION
    Labeler DUNS
    690542881
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-11-17
    Public Version
    1
    Public Version Date
    2025-11-25
    Public Version Status
    New
    Public Device Record Key
    e7c417cf-6ca2-4cb7-8a11-d5aab602eb2b

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    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
    HKX Tonometer, ac-powered
    MXK Device, Analysis, Anterior Segment

    GMDN Terms

    Code Name
    67414 Ophthalmic tonometer, professional

    Identifiers

    Type ID
    Primary 04571130283343