BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    OMRON HEALTHCARE CO., LTD.

    Reg #: 8030245 · FEI: 3004072282 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    12

    Registration Details

    Registration Name
    OMRON HEALTHCARE CO., LTD.
    Registration Number
    8030245
    FEI Number
    3004072282
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Kunotsubo 53, Terado-Cho
    City
    MUKO Kyoto
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K182579

    Owner / Operator

    Firm Name
    OMRON HEALTHCARE CO., LTD.
    Operator Number
    8030246
    Address
    53, Kunotsubo, Terado-cho
    City
    MUKO
    State
    Kyoto
    Postal Code
    617-0002
    Country
    JP

    US Agent

    Business Name
    OMRON HEALTHCARE, INC.
    Contact Name
    Terri Ingalls
    Address
    2895 Greenspoint Parkway, Suite 100
    City
    Hoffman Estates
    State
    IL
    ZIP
    60169
    Country
    US
    Email
    [email protected]
    Phone
    847 2475657

    Products

    Device Name Product Code
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Electrocardiograph DPS
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
    Stimulator, Electrical, Transcutaneous, For Arthritis NYN
    Nebulizer (Direct Patient Interface) CAF
    Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature QXY
    Analyzer, Body Composition MNW
    Electrode, Cutaneous GXY
    Electrocardiograph Software For Over-The-Counter Use QDA
    Analyzer, Body Composition, Exempt PUH
    Scale, Stand-On, Patient FRI

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility