BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IRRAflow CNS System

    Reg #: 1836324 · FEI: 3002998595 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Rose Medical
    Registration Number
    1836324
    FEI Number
    3002998595
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1440 Front Ave NW
    City
    Grand Rapids
    State
    MI
    ZIP
    49504
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171880

    Owner / Operator

    Firm Name
    Rose Medical
    Operator Number
    10042209
    Address
    1440 Front Avenue NW
    City
    Grand Rapids
    State
    MI
    Postal Code
    49504
    Country
    US
    Correspondent
    Eric Vroegop

    Products

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

    Proprietary Names

    IRRAflow CNS System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)