BEUDAMED
    Product Code: MBU FDA class 2 21 CFR 884.5340

    Single-Use Internal Condom

    Obstetrics/Gynecology

    The single-use internal condom is a contraceptive and barrier protection device intended for use inside the vagina to prevent pregnancy and reduce transmission of sexually transmitted infections during coitus, and is removed and discarded after use. It is classified as FDA Class II under 21 CFR 884.5340 within the Obstetrics/Gynecology specialty, requiring 510(k) premarket clearance. The product code is MBU and the device is not implanted nor life-sustaining. Full GMP compliance is required.

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    510(k)s
    0
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    MBU
    Device Class
    FDA class 2
    Regulation Number
    884.5340
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    For contraception and/or prophylactic (preventing the transmission of sexually transmitted infections) purposes. At the conclusion of coitus, it is removed and discarded.

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.