BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    FURUNO ELECTRIC CO., LTD.

    Reg #: 3004438098 · FEI: 3004438098 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    FURUNO ELECTRIC CO., LTD.
    Registration Number
    3004438098
    FEI Number
    3004438098
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2-20, Nishinomiyahama
    City
    NISHINOMIYA-CITY Hyogo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K052914

    Owner / Operator

    Firm Name
    Furuno Electric Co., Ltd.
    Operator Number
    9048176
    Address
    9-52 Ashihara-Cho
    City
    Nishinomiya-City
    State
    Hyogo
    Postal Code
    662-8580
    Country
    JP

    US Agent

    Business Name
    Furuno U.S.A., Inc.
    Contact Name
    Bradley Reents
    Address
    4400 N.W. Pacific Rim Boulevard
    City
    Camas
    State
    WA
    ZIP
    98607
    Country
    US
    Email
    [email protected]
    Phone
    360 8349300

    Products

    Device Name Product Code
    Electrode, Ion Specific, Sodium JGS
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Electrode, Ion-Specific, Chloride CGZ
    Photometric Method, Magnesium JGJ
    Electrode, Ion Specific, Potassium CEM
    Glucose Oxidase, Glucose CGA
    Analyzer, Chemistry, Micro, For Clinical Use JJF
    Calibrator, Multi-Analyte Mixture JIX
    Hexokinase, Glucose CFR
    Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes CJE
    Nadh Oxidation/Nad Reduction, Ast/Sgot CIT

    Proprietary Names

    RX Imola RX Daytona Poly-Chem Poly-Chem 90

    Establishment Types

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