BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    e411

    Reg #: 3014840402 · FEI: 3014840402 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Hitachi High-Tech Corp., Omuta Center
    Registration Number
    3014840402
    FEI Number
    3014840402
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1892-1 Tegama
    City
    Omuta-shi Fukuoka
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K961481

    Owner / Operator

    Firm Name
    HITACHI HIGH-TECH CORP.
    Operator Number
    9049564
    Address
    1-17-1 Toranomon,, --
    City
    Minato-ku
    State
    Tokyo
    Postal Code
    105-6409
    Country
    JP

    Products

    Device Name Product Code
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE

    Proprietary Names

    e411 ELECSYS 2010 ANALYZER MODULAR E

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)