BEUDAMED
    Product Code: RFX FDA not classified

    Cd-R, Cd-Rw Recorder

    Unknown

    The CD-R/CD-RW Recorder is a device that incorporates a laser to both read and write data on recordable and rewritable compact discs. It is classified as FDA Not Classified (Class N) with product code RFX and is GMP-exempt. The product has no associated regulation number or medical specialty, reflecting its use as a standard consumer or office data storage device. No implant or life-sustaining flags are noted. The FDA regulates such devices under electronic product radiation control provisions due to their internal laser components.

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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
    RFX
    Device Class
    FDA not classified
    Medical Specialty
    Unknown

    Device Characteristics

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

    Definition

    A cd-r or cd-rw recorder machine that utilizes a laser to read and/or write data on the compact disc.