BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    OMRON HEALTHCARE Co., Ltd. Matsusaka Factory

    Reg #: 9611045 · FEI: 3002807674 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OMRON HEALTHCARE Co., Ltd. Matsusaka Factory
    Registration Number
    9611045
    FEI Number
    3002807674
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1855-370 KUBO-CHO
    City
    Matsusaka Mie
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K190693

    Owner / Operator

    Firm Name
    OMRON HEALTHCARE Co., Ltd. Matsusaka Factory
    Operator Number
    9039325
    Address
    1855-370, Kubo-cho
    City
    Matsusaka
    State
    Mie
    Postal Code
    515-8503
    Country
    JP
    Correspondent
    SATOSHI KOIKE

    US Agent

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

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)