BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    ELITe InGenius

    Reg #: 3005748784 · FEI: 3005748784 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    YAMURA ELECTRIC INDUSTRY CO., LTD.
    Registration Number
    3005748784
    FEI Number
    3005748784
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    21-26-18 MURASAKINO
    City
    KITAKAMI-SHI Iwate
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K180559

    Owner / Operator

    Firm Name
    YAMURA ELECTRIC INDUSTRY CO., LTD.
    Operator Number
    9087659
    Address
    21-26-18 MURASAKINO, --
    City
    KITAKAMI-SHI
    State
    Iwate
    Postal Code
    024-0004
    Country
    JP
    Correspondent
    SATOSHI - SOTOMURA

    US Agent

    Business Name
    Jataki Company LLC
    Contact Name
    Derek Wessman
    Address
    88 W Lake View Terrace Rd
    City
    Saratoga Springs
    State
    UT
    ZIP
    84045
    Country
    US
    Email
    [email protected]
    Phone
    801 6569278

    Products

    Device Name Product Code
    Real Time Nucleic Acid Amplification System OOI

    Proprietary Names

    ELITe InGenius

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)