BEUDAMED
    Product Code: MMH FDA class 2 21 CFR 864.9165

    Blood Establishment Computer Software And Accessories

    Hematology

    Blood Establishment Computer Software and Accessories are software systems and associated hardware used by blood banks and transfusion centers to manage and automate processes related to blood collection, donor screening, component processing, compatibility testing, and distribution, ensuring the safety and traceability of the blood supply. Classified as a Class 2 device under 21 CFR 864.9165 within the Hematology specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    0
    FEI Numbers
    45
    Registration Numbers
    45
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MMH
    Device Class
    FDA class 2
    Regulation Number
    864.9165
    Medical Specialty
    Hematology
    Review Panel
    HE
    Submission Type
    1

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 45 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 45 registration numbers. Click on an entry to view related FDA registrations.