BEUDAMED
    Product Code: MQI FDA class 2 21 CFR 884.6140

    Microtool Fabrication, Assisted Reproduction

    Obstetrics/Gynecology

    Microtool Fabrication devices for Assisted Reproduction are obstetrics/gynecology devices used to create or manufacture the precision microtools (such as micropipettes) needed for ART procedures including intracytoplasmic sperm injection and embryo manipulation. Classified as FDA Class 2 under 21 CFR 884.6140, they require 510(k) premarket notification. The product code is MQI, and they are eligible for third-party 510(k) review.

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

    Product Code
    MQI
    Device Class
    FDA class 2
    Regulation Number
    884.6140
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    1

    Device Characteristics

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