BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Neuescue Device

    Reg #: 3005255160 · FEI: 3005255160 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ARROTEK MEDICAL LTD
    Registration Number
    3005255160
    FEI Number
    3005255160
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Finisklin Business Park
    City
    Co. Sligo Connaught
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K210358

    Owner / Operator

    Firm Name
    Arrotek Medical Ltd
    Operator Number
    10033099
    Address
    Finisklin Business Park
    City
    Co. Sligo
    State
    Connaught
    Postal Code
    F91 P499
    Country
    IE

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Catheter, Intravascular Occluding, Temporary MJN
    Catheter, Intravascular, Diagnostic DQO
    Catheter, Percutaneous DQY

    Proprietary Names

    Neuescue Device

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)