BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Solo+ TTD

    Reg #: 3012112259 · FEI: 3012112259 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    AVENTAMED DAC
    Registration Number
    3012112259
    FEI Number
    3012112259
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rubicon Centre, Rossa Avenue
    City
    Bishopstown Cork
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K250256

    Owner / Operator

    Firm Name
    AventaMed DAC
    Operator Number
    10091035
    Address
    Rubicon Centre, Rossa Avenue
    City
    Bishopstown
    State
    Cork
    Postal Code
    T12Y275
    Country
    IE
    Correspondent
    John Vaughan

    US Agent

    Business Name
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Contact Name
    Anja Fair
    Address
    2151 E Grand Ave
    City
    El Segundo
    State
    CA
    ZIP
    90245
    Country
    US
    Email
    [email protected]
    Phone
    346 8168200

    Products

    Device Name Product Code
    Tube, Tympanostomy ETD

    Proprietary Names

    Solo+ TTD

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility