BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ISE Standard Low 10x3ML

    Reg #: 1000414342 · FEI: 1000414342 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    EVER PHARMA JENA
    Registration Number
    1000414342
    FEI Number
    1000414342
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Otto-Schott-Str. 15
    City
    Jena Thuringia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K963627

    Owner / Operator

    Firm Name
    EVER Pharma Jena
    Operator Number
    10055008
    Address
    Otto-Schott-Str. 15
    City
    Jena
    State
    Thuringia
    Postal Code
    07745
    Country
    DE
    Correspondent
    Maximilian Pitscheider

    US Agent

    Business Name
    Roche Diagnostics Operations Inc
    Contact Name
    Brian Frazier
    Address
    9115 Hague Rd
    City
    Indianapolis
    State
    IN
    ZIP
    46256
    Country
    US
    Email
    [email protected]
    Phone
    317 5214603

    Products

    Device Name Product Code
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion Specific, Potassium CEM
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Calibrator, Multi-Analyte Mixture JIX
    Electrode, Ion-Specific, Chloride CGZ

    Proprietary Names

    ISE Standard Low 10x3ML ISE Standard High 10x3ML

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)