BEUDAMED
    Product Code: HRE FDA class 1 21 CFR 886.1860

    Cabinet, Instrument, Ac-Powered, Ophthalmic

    Ophthalmic

    An AC-Powered Ophthalmic Instrument Cabinet is an electrically powered storage and organizational unit designed for use in ophthalmic examination or surgical settings, providing controlled storage conditions for ophthalmic instruments, lenses, and accessories. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification. It carries product code HRE and is regulated under 21 CFR 886.1860, within the Ophthalmic medical 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
    HRE
    Device Class
    FDA class 1
    Regulation Number
    886.1860
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    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.