BEUDAMED
    Product Code: MCM FDA class 3

    Implant, Cochlear

    Unknown

    The cochlear implant is a surgically placed electronic hearing device that bypasses damaged portions of the inner ear and directly stimulates the auditory nerve with electrical signals, enabling perception of sound in individuals with severe to profound sensorineural hearing loss. It is classified as FDA Class III, requiring Premarket Approval (PMA) with rigorous clinical evidence of safety and effectiveness. The product code is MCM and it carries an implant flag reflecting its permanent surgical placement. No regulation number or formal medical specialty has been assigned in this record.

    View on FDA
    510(k)s
    0
    FEI Numbers
    23
    Registration Numbers
    23
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MCM
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    EN
    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 23 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.