BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    HMS-CS 4.3

    Reg #: 9617476 · FEI: 1000628323 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    IEM GMBH
    Registration Number
    9617476
    FEI Number
    1000628323
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Gewerbepark Brand 42
    City
    Aachen North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K110603

    Owner / Operator

    Firm Name
    IEM GMBH
    Operator Number
    9035831
    Address
    Gewerbepark Brand 42, --
    City
    Aachen
    State
    North Rhine-Westphalia
    Postal Code
    D-52078
    Country
    DE
    Correspondent
    Daniel - Di Martino

    US Agent

    Business Name
    gatc LP
    Contact Name
    Bianca Kuennecke
    Address
    5126 South Royal Atlanta Drive
    City
    Tucker
    State
    GA
    ZIP
    30084
    Country
    US
    Email
    [email protected]
    Phone
    770 4939305

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    HMS-CS 4.3 HMS-CS 4.7

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device