BEUDAMED
    Product Code: NEP FDA class 2 21 CFR 880.5440

    System/Device, Pharmacy Compounding

    General Hospital

    The System/Device, Pharmacy Compounding (product code NEP) is a device used in pharmacy compounding operations to prepare, mix, or compound medications in a controlled manner. It is classified as an FDA Class 2 device within the General Hospital specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    0
    FEI Numbers
    52
    Registration Numbers
    52
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    NEP
    Device Class
    FDA class 2
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Review Panel
    HO
    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 52 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 52 registration numbers. Click on an entry to view related FDA registrations.