BEUDAMED
    FDA Registration Active 🇨🇳 China

    i15 Blood Gas and Electrolyte Control

    Reg #: 3003971136 · FEI: 3003971136 · Expires 2025
    View on FDA
    Products
    9
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    9

    Registration Details

    Registration Name
    EDAN INSTRUMENTS, INC.
    Registration Number
    3003971136
    FEI Number
    3003971136
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K151978

    Owner / Operator

    Firm Name
    EDAN INSTRUMENTS, INC.
    Operator Number
    9055347
    Address
    #15 Jinhui Road,Jinsha Community, Kengzi Sub-District, Pingshan District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518122
    Country
    CN

    US Agent

    Business Name
    Edan Diagnostics, Inc
    Contact Name
    Chao Lin
    Address
    9918 Via Pasar, San Diego CA
    City
    San Diego
    State
    CA
    ZIP
    92126
    Country
    US
    Email
    [email protected]
    Phone
    858 7503066

    Products

    Device Name Product Code
    Calibrator, Multi-Analyte Mixture JIX
    Electrode, Ion Specific, Calcium JFP
    Instrument, Hematocrit, Automated GKF
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion-Specific, Chloride CGZ
    Controls For Blood-Gases, (Assayed And Unassayed) JJS
    Control, Hematocrit GLK
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
    Electrode, Ion Specific, Potassium CEM

    Proprietary Names

    i15 Blood Gas and Electrolyte Control i15 Calibrant Fluid Pack i15 Hematocrit Control i15 Blood Gas and Chemistry Analysis System i15A Blood Gas and Electrolyte Control i15A Hematocrit Control i15A Calibrant Fluid Pack i15A Blood Gas and Chemistry Analysis System

    Establishment Types

    Manufacture Medical Device