BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    i3 ONE

    Reg #: 3022699154 · FEI: 3022699154 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    i3 Membrane GmbH
    Registration Number
    3022699154
    FEI Number
    3022699154
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Christoph-Seydel-Strasse 1
    City
    Radeberg Saxony
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K222727

    Owner / Operator

    Firm Name
    i3 Membrane GmbH
    Operator Number
    10088961
    Address
    Theodorstrasse 41P
    City
    Hamburg
    State
    DE-HH
    Postal Code
    22761
    Country
    DE
    Correspondent
    Thor H Meyer

    US Agent

    Business Name
    i3 Membrane Corporation
    Contact Name
    Kenneth Renfrew
    Address
    11330 Vanstory Drive
    City
    Huntersville
    State
    NC
    ZIP
    28078
    Country
    US
    Email
    [email protected]
    Phone
    980 8888117

    Products

    Device Name Product Code
    System, Water Purification, General Medical Use NHV

    Proprietary Names

    i3 ONE i3 TWO connect i3 TWO direct

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device