BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Infravision Universal Ureteral kit

    Reg #: 3008328690 · FEI: 3008328690 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    VISTAMED LTD T/A Freudenberg Medical.
    Registration Number
    3008328690
    FEI Number
    3008328690
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    IDA Business & Technology Park, Carrick On Shannon, CO, Leitrim
    City
    Leitrim
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K061548

    Owner / Operator

    Firm Name
    VistaMed Ltd t/a Freudenberg Medical
    Operator Number
    10031914
    Address
    IDA Business and Technology Park
    City
    Carrick-on-Shannon
    State
    Leitrim
    Postal Code
    0000
    Country
    IE
    Correspondent
    Declan Whyte

    US Agent

    Business Name
    Freudenberg Medical, LLC
    Contact Name
    Juan Carlos Llamas
    Address
    1110 Mark Ave.
    City
    Carpinteria
    State
    CA
    ZIP
    93013
    Country
    US
    Email
    [email protected]
    Phone
    805 5765317

    Products

    Device Name Product Code
    Light, Catheter, Fiberoptic, Glass, Ureteral FCS

    Proprietary Names

    Infravision Universal Ureteral kit

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)