BEUDAMED
    Product Code: MDP FDA class 3

    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

    Unknown

    The automated membrane blood cell/plasma separator for therapeutic purposes is a blood processing device used to separate cellular blood components from plasma in therapeutic apheresis procedures, such as treatment of immune-mediated or hematologic conditions. It is classified as FDA Class III, requiring Premarket Approval (PMA) with clinical evidence of safety and effectiveness. The product code is MDP 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
    7
    Registration Numbers
    7
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    MDP
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    GU
    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 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.