BEUDAMED
    Product Code: MGR FDA class 3

    Dressing, Wound And Burn, Interactive

    Unknown

    The interactive wound and burn dressing is a wound care device designed to interact with the wound environment, such as by absorbing exudate, managing moisture, or promoting healing through active mechanisms, distinguishing it from passive dressings. It is classified as FDA Class III, requiring Premarket Approval (PMA) with clinical evidence of safety and effectiveness. The product code is MGR and no regulation number or formal medical specialty has been assigned. The device is not an implant and does not sustain life.

    View on FDA
    510(k)s
    0
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MGR
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    SU
    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 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.