BEUDAMED
    Product Code: GMB FDA class 1 21 CFR 866.2600

    Light, Wood'S, Fluorescence

    Microbiology

    Wood's Light (Fluorescence Lamp) is a diagnostic instrument that emits ultraviolet light used in microbiology and dermatology laboratories to detect certain fungal infections, bacterial infections, and skin conditions that fluoresce under UV illumination. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from Good Manufacturing Practice (GMP) requirements. The product code is GMB, regulated under 21 CFR 866.2600 in the Microbiology specialty.

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    510(k)s
    0
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    GMB
    Device Class
    FDA class 1
    Regulation Number
    866.2600
    Medical Specialty
    Microbiology
    Review Panel
    MI
    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 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.