BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cystosure XL

    Reg #: 3010314836 · FEI: 3010314836 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EMMY MEDICAL, LLC
    Registration Number
    3010314836
    FEI Number
    3010314836
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    18 Hillside Dr
    City
    Holliston
    State
    MA
    ZIP
    01746
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181346

    Owner / Operator

    Firm Name
    Emmy Medical, LLC
    Operator Number
    10048747
    Address
    18 Hillside Drive
    City
    Holliston
    State
    MA
    Postal Code
    01746
    Country
    US
    Correspondent
    Ronald D Adams

    Products

    Device Name Product Code
    Catheter, Retention Type, Balloon EZL

    Proprietary Names

    Cystosure XL

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility