BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    DIASYS DIAGNOSTIC SYSTEMS GMBH

    Reg #: 3006644620 · FEI: 3006644620 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    DIASYS DIAGNOSTIC SYSTEMS GMBH
    Registration Number
    3006644620
    FEI Number
    3006644620
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ALTE STRASSE 9
    City
    Holzheim Rhineland-Palatinate
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K242294

    Owner / Operator

    Firm Name
    DIASYS DIAGNOSTIC SYSTEMS GMBH
    Operator Number
    9105042
    Address
    ALTE STRASSE 9, --
    City
    HOLZHEIM, RHEINLAND-PFALZ
    State
    DE-NOTA
    Postal Code
    D-65558
    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
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission PTF
    Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides CDT
    Calibrator, Multi-Analyte Mixture JIX
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN

    Proprietary Names

    DiaSys TruLab Procalcitonin Bi-Level Controls DiaSys Procalcitonin FS Assay DiaSys TruCaI Procalcitonin Calibrator Set ?-Hydroxybutyrate 21 Tri-Level Controls ?-Hydroxybutyrate 21 Bi-Level Controls Atellica CH Triglycerides_2 ?-Hydroxybutyrate 21 Linearity Standards Atellica CH Bilirubin Calibrator ?-Hydroxybutyrate 21 FS

    Establishment Types

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