BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MOPTIM

    DI: 06972039971054 · Model: C1 · Shenzhen CERTAINN Technology Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MOPTIM
    Primary DI
    06972039971054
    Version / Model
    C1
    Company Name
    Shenzhen CERTAINN Technology Co., Ltd.
    Labeler DUNS
    526992561
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-08-15
    Public Version
    1
    Public Version Date
    2025-08-25
    Public Version Status
    New
    Public Device Record Key
    e256c005-0956-4283-a57a-d5afe08d3754

    Device Description

    C1 is a non-contact diagnostic method that measures the shape of the corneal surface, providing key parameters such as corneal curvature and refractive power. Utilizing an advanced Placido disk, it accurately captures topographical changes around the cornea and enables analysis of higher-order aberrations. This device is essential for routine ophthalmic examinations of the cornea.

    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    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
    45734 Corneal topography system analyser

    Identifiers

    Type ID
    Primary 06972039971054