BEUDAMED
    Product Code: KJE FDA class 1 21 CFR 864.2240

    Spinner System, Cell Culture

    Hematology

    Cell Culture Spinner System is an integrated laboratory system combining spinner flasks or bioreactor vessels with associated drives, controls, and accessories designed to maintain cells in continuous suspension under controlled agitation, supporting scalable production of cells or biologics in in vitro laboratory applications. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KJE, regulated under 21 CFR 864.2240, within the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

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    510(k)s
    0
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    KJE
    Device Class
    FDA class 1
    Regulation Number
    864.2240
    Medical Specialty
    Hematology
    Review Panel
    PA
    Submission Type
    4

    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.