BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    EKF DIAGNOSTIC GMBH

    Reg #: 3004838836 · FEI: 3004838836 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    21
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    EKF DIAGNOSTIC GMBH
    Registration Number
    3004838836
    FEI Number
    3004838836
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    EBENDORFER CHAUSEE 3
    City
    BARLEBEN/MADGEBURG Saxony-Anhalt
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K110393

    Owner / Operator

    Firm Name
    EKF DIAGNOSTIC GMBH
    Operator Number
    9057009
    Address
    EBENDORFER CHAUSEE 3, BARLEBEN/MADGEBURG
    City
    SAXONY-ANHALT
    State
    DE-NOTA
    Postal Code
    D-39179
    Country
    DE

    US Agent

    Business Name
    Imagenix, Inc.
    Contact Name
    Stephen Gorski
    Address
    S65W35739 Piper Road
    City
    Eagle
    State
    WI
    ZIP
    53119
    Country
    US
    Email
    [email protected]
    Phone
    414 7374596

    Products

    Device Name Product Code
    Calculator/Data Processing Module, For Clinical Use JQP
    System, Hemoglobin, Automated GKR
    Whole Blood Hemoglobin Determination KHG
    Control, Hemoglobin GGM

    Proprietary Names

    EKF Link EKF Diagnostic Hemo_Control Hemoglobin Measurement System Hemo_Control microcuvettes Consult Hb Control Solution High Level DiaSpect TM Analyzer DiaSpect TM Cuvettes Consult Hb Control Solution Medium Level Consult Hb Control Solution Low Level Consult diagnostics Hemoglobin Analyzer Consult diagnostics Hemoglobin Cuvettes Hemo-Control Hemo Control DiaSpect Control Pack HBT4 (90B014) DiaSpect Control Pack HBT3 (90B013) DiaSpect Control Pack HBT2 (90B012) DiaSpect Control HBT1 DiaSpect Control HBT2 DiaSpect Control HBT3 DiaSpect Control HBT4 DiaSpect Tm Cuvettes DiaSpect Tm

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility