BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IRRAflow Catheter, IRRAflow tube set, IRRAflow Control Unit

    Reg #: 3013944123 · FEI: 3013944123 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Eurofins Infinity Laboratory Group Inc.
    Registration Number
    3013944123
    FEI Number
    3013944123
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1836 Stone Ave
    City
    San Jose
    State
    CA
    ZIP
    95125
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192289

    Owner / Operator

    Firm Name
    Eurofins - Infinity Laboratory Group Inc.
    Operator Number
    10080298
    Address
    1836 Stone Ave
    City
    San Jose
    State
    CA
    Postal Code
    95125
    Country
    US
    Correspondent
    Jennifer Eagan

    Products

    Device Name Product Code
    Shunt, Central Nervous System And Components JXG
    Device, Monitoring, Intracranial Pressure GWM

    Proprietary Names

    IRRAflow Catheter, IRRAflow tube set, IRRAflow Control Unit

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)