BEUDAMED
    Product Code: MRJ FDA class 3

    Ring, Endocapsular

    Unknown

    The Endocapsular Ring is an ophthalmic implant placed inside the capsular bag of the eye during cataract surgery to stabilize a weak or damaged capsule, supporting placement of an intraocular lens in eyes with zonular instability or pseudoexfoliation syndrome. Classified as FDA Class 3 due to the high-risk nature of this novel implant, it requires Premarket Approval (PMA). The product code is MRJ, reviewed by the Ophthalmic panel, and carries an implant flag.

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    510(k)s
    0
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    MRJ
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    OP
    Submission Type
    2

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.