BEUDAMED
    Product Code: RAC FDA not classified

    Nondestructive Tests

    Unknown

    The nondestructive tests classification (product code RAC) covers ultrasound-based test equipment used to analyze objects for defects in commercial or industrial applications, with no medical purpose. These devices are not classified within the standard medical device framework (Class 1/2/3) and are GMP-exempt. No regulation number, medical specialty, or submission type is assigned.

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

    Product Code
    RAC
    Device Class
    FDA not classified
    Medical Specialty
    Unknown

    Device Characteristics

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

    Definition

    Test equipment using ultrasound to analyze an object for defects in commercial or industrial applications