BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AUTO KERATO-REFRACTOMETER KR-800

    DI: 04560126269140 · Model: KR-800 · TOPCON CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    AUTO KERATO-REFRACTOMETER KR-800
    Primary DI
    04560126269140
    Version / Model
    KR-800
    Company Name
    TOPCON CORPORATION
    Labeler DUNS
    690542881
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-10-31
    Public Version
    1
    Public Version Date
    2025-11-10
    Public Version Status
    New
    Public Device Record Key
    f6c16798-d152-40ba-bcee-9a1797989b0e

    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
    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
    HKO Refractometer, Ophthalmic

    GMDN Terms

    Code Name
    36386 Automated ophthalmic refractometer

    Identifiers

    Type ID
    Primary 04560126269140