BEUDAMED
    Product Code: MYJ FDA class 2 21 CFR 864.9195

    Device, Mixing And Weighing, Semi-Automated

    Hematology

    The Semi-Automated Mixing and Weighing Device is a laboratory instrument used in hematology settings to semi-automatically mix and weigh blood components or reagents with precision, supporting blood banking and transfusion medicine procedures. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 864.9195 (Hematology specialty).

    View on FDA
    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MYJ
    Device Class
    FDA class 2
    Regulation Number
    864.9195
    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 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.