BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    YO Home Sperm Test

    DI: 07290016650211 · Model: For Galaxy J2 · M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    YO Home Sperm Test
    Primary DI
    07290016650211
    Version / Model
    For Galaxy J2
    Company Name
    M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
    Labeler DUNS
    514680529
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-06-26
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    21db21fe-8468-4381-9dc7-fd78f3beb153

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    Yes
    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
    No
    Has Serial Number
    No
    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
    POV Semen Analysis Device

    GMDN Terms

    Code Name
    61920 Motile sperm concentration IVD, kit, imaging, self-testing

    Identifiers

    Type ID
    Primary 07290016650211