BEUDAMED
    Product Code: MDD FDA class 3

    Device, Dermal Replacement

    Unknown

    The dermal replacement device is a surgical implant used as a substitute for damaged or absent dermis in patients with significant wounds, burns, or surgical defects, providing a scaffold for tissue regeneration and wound closure. It is classified as FDA Class III, requiring Premarket Approval (PMA) with clinical evidence of safety and effectiveness. The product code is MDD and it carries an implant flag; no regulation number or formal medical specialty has been assigned. It 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
    MDD
    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 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.