BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Rexxam

    DI: 04540008310436 · Model: ACCUREF K-900 · REXXAM CO., LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Rexxam
    Primary DI
    04540008310436
    Version / Model
    ACCUREF K-900
    Catalog Number
    RK453
    Company Name
    REXXAM CO., LTD.
    Labeler DUNS
    704538487
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-10-17
    Public Version
    1
    Public Version Date
    2025-10-27
    Public Version Status
    New
    Public Device Record Key
    3eb3b1b3-edf0-4d78-9363-36713ea99633

    Device Description

    This device aims to objectively measure the refractive power of the eye by using the light that is projected to and reflected from the eyeground. It also aims to measure the radius of corneal curvature by using the light that is projected to and reflected from the cornea. Moreover, it can measure the pupil diameter by taking the image of the anterior eye of the examinee.

    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
    HKO Refractometer, Ophthalmic

    GMDN Terms

    Code Name
    36386 Automated ophthalmic refractometer

    Identifiers

    Type ID
    Primary 04540008310436