BEUDAMED
    Product Code: EXS FDA class 2 21 CFR 876.1800

    Urinometer, Electrical

    Gastroenterology, Urology

    The electrical urinometer is an electronic device used to measure the specific gravity or osmolality of urine to assess kidney concentrating function and hydration status. It is classified as FDA Class 2, indicating moderate risk, and is subject to special controls. The product code is EXS, regulated under 21 CFR 876.1800 in the Gastroenterology, Urology specialty. No special implant, life-sustaining, or GMP-exempt flags apply.

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    510(k)s
    0
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    EXS
    Device Class
    FDA class 2
    Regulation Number
    876.1800
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    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 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.