BEUDAMED
    FDA Registration Active 🇨🇿 Czechia

    Inogen Rove 6™ Portable Oxygen Concentrator System

    Reg #: 3014661487 · FEI: 3014661487 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FOXCONN EUROPEAN MANUFACTURING SERVICES S.R.O.
    Registration Number
    3014661487
    FEI Number
    3014661487
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    U Zamecku 27, Pardubicky
    City
    Pardubice
    Country
    CZ

    Regulatory Submissions

    510(k) Number
    K032818

    Owner / Operator

    Firm Name
    Foxconn European Manufacturing Services s.r.o.
    Operator Number
    10059678
    Address
    U Zamecku 27, Pardubicky
    City
    Pardubice
    State
    CZ-532
    Postal Code
    53003
    Country
    CZ
    Correspondent
    Filip Hanus

    Products

    Device Name Product Code
    Generator, Oxygen, Portable CAW

    Proprietary Names

    Inogen Rove 6™ Portable Oxygen Concentrator System Inogen One G5 Oxygen Concentrator

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)