BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ?-Hydroxybutyrate 21 Linearity Standards

    Reg #: 3006644620 · FEI: 3006644620 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DIASYS DIAGNOSTIC SYSTEMS GMBH
    Registration Number
    3006644620
    FEI Number
    3006644620
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ALTE STRASSE 9
    City
    Holzheim Rhineland-Palatinate
    Country
    DE

    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
    DiaSys Diagnostic Systems, USA, LLC
    Contact Name
    Markus Rick
    Address
    28287 Beck Road, Building D-15
    City
    Wixom
    State
    MI
    ZIP
    48393
    Country
    US
    Email
    [email protected]
    Phone
    800 4669106

    Products

    Device Name Product Code
    Calibrator, Multi-Analyte Mixture JIX

    Proprietary Names

    ?-Hydroxybutyrate 21 Linearity Standards Atellica CH Bilirubin Calibrator

    Establishment Types

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