BEUDAMED
    Product Code: HJR FDA class 1 21 CFR 886.1870

    Stereoscope, Battery-Powered

    Ophthalmic

    The Battery-Powered Ophthalmic Stereoscope is a portable device used to assess binocular vision and stereoscopic perception by presenting a distinct image to each eye, supporting evaluation of ocular alignment and depth perception. It is classified as FDA Class 1, representing the lowest risk category, requiring only general controls without a premarket submission. The product code is HJR, regulated under 21 CFR 886.1870, within the Ophthalmic medical specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements under 21 CFR Part 820.

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    510(k)s
    0
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    HJR
    Device Class
    FDA class 1
    Regulation Number
    886.1870
    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 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.