BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Unscented menstrual three-piece applicator tampon

    K Number: K252613 · Decision Sep 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    188
    Applicant Total
    4
    Review Days
    31

    Basic Information

    Device Name
    Unscented menstrual three-piece applicator tampon
    K Number
    K252613
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.5470
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Unibeauty (Hubei) Technology Co., Ltd.
    Date Received
    August 19, 2025
    Decision Date
    September 19, 2025
    Product Code
    HEB
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HEB Tampon, Menstrual, Unscented

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HEB), ordered by most recent decision date.

    Livi Device

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SABA Tampons

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Unscented Tampon

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Unibeauty (Hubei) Technology Co., Ltd.

    K Number Device Name
    K253719 Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons
    K251033 Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons
    K232598 Unscented Menstrual Tampon