BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MediWorks

    DI: 06945087510018 · Model: V100 · SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MediWorks
    Primary DI
    06945087510018
    Version / Model
    V100
    Company Name
    SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
    Labeler DUNS
    527884077
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-04-04
    Public Version
    1
    Public Version Date
    2019-04-12
    Public Version Status
    New
    Public Device Record Key
    9b61b1b6-3c05-4633-905d-0724ce9a5f1b

    Device Description

    The vision screening instrument is based on the principle of eccentric photo refraction and is used for screening myopia, hyperopia and astigmatism. Refraction, eye position, pupil, pupil distance and other information can be obtained for doctors to diagnose eye diseases.

    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
    46390 Vision/eye movement analysis system

    Identifiers

    Type ID
    Primary 06945087510018