BEUDAMED
    Product Code: MFE FDA class 3

    Agent, Injectable, Embolic

    Unknown

    The injectable embolic agent is an interventional radiology or vascular device administered through a catheter to intentionally occlude blood vessels, used for embolization procedures to treat conditions such as vascular malformations, tumors, hemorrhage, or uterine fibroids. It is classified as FDA Class III, requiring Premarket Approval (PMA) with clinical evidence of safety and effectiveness. The product code is MFE and no regulation number or formal medical specialty has been assigned. The device is not flagged as an implant and does not sustain life.

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

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    Basic Information

    Product Code
    MFE
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    NE
    Submission Type
    2

    Device Characteristics

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

    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.