BEUDAMED
    Product Code: MXT FDA class 1 21 CFR 864.3010

    Device, Accessory, Cooling Plate For Tissue Embedding Station

    Pathology

    The Cooling Plate Accessory for Tissue Embedding Station is a laboratory pathology device used as an accessory to tissue embedding stations, providing controlled cooling to solidify paraffin wax blocks containing tissue specimens for histological processing. Classified as FDA Class 1, it is subject to general controls and is GMP-exempt under regulation 864.3010 (Pathology specialty). As a low-risk laboratory accessory, it represents minimal patient safety risk.

    View on FDA
    510(k)s
    0
    FEI Numbers
    25
    Registration Numbers
    25
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    MXT
    Device Class
    FDA class 1
    Regulation Number
    864.3010
    Medical Specialty
    Pathology
    Review Panel
    CH
    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 25 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.