BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OvuSense

    DI: 05060508530114 · Model: M032 Android · VIO HEALTHTECH LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OvuSense
    Primary DI
    05060508530114
    Version / Model
    M032 Android
    Company Name
    VIO HEALTHTECH LIMITED
    Labeler DUNS
    347449352
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-07-23
    Public Version
    2
    Public Version Date
    2023-01-31
    Public Version Status
    Update
    Public Device Record Key
    022032b2-620c-4600-bba1-a12fad54eb75

    Device Description

    OvuSense 2 App - Android

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LHD Device, Fertility Diagnostic, Proceptive

    GMDN Terms

    Code Name
    36110 Thermometric fertility analyser

    Identifiers

    Type ID
    Primary 05060508530114