BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SmartBand EMR Kit (SBEMRK94)

    Reg #: 3011324403 · FEI: 3011324403 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Intelligent Endoscopy
    Registration Number
    3011324403
    FEI Number
    3011324403
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4740 Commercial Park Ct Ste 1
    City
    Clemmons
    State
    NC
    ZIP
    27012
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212860

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    10048186
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Snare, Flexible FDI

    Proprietary Names

    SmartBand EMR Kit (SBEMRK94) SmartSnare EMR Hexagonal Snare (SS-230-1) SmartBand EMR Pack (SBEMRP94)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility