BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    femometer

    DI: 06972412612000 · Model: FM-IVY-104 · Hangzhou Laihe Biotech Co.,Ltd.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    femometer
    Primary DI
    06972412612000
    Version / Model
    FM-IVY-104
    Company Name
    Hangzhou Laihe Biotech Co.,Ltd.
    Labeler DUNS
    543330912
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-04-25
    Public Version
    1
    Public Version Date
    2024-05-03
    Public Version Status
    New
    Public Device Record Key
    cb0f40a9-fd59-4eb3-8fa8-0f17d9da56e4

    Device Description

    This product is a rapid, one-step, visual test for the qualitative detection of follicle stimulating hormone (FSH) in human urine. It is intended for self-testing. It is to be used as a confirmation of body hormone changes related to the symptoms associated with the changes of menopause and as an adjunctive screen of fertility for home use by women who are attempting to conceive but have been unsuccessful.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    Yes
    Combination Product
    Yes
    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
    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

    GMDN Terms

    Code Name
    54188 Follicle stimulating hormone (FSH) IVD, reagent

    Identifiers

    Type ID
    Primary 06972412612000