BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    c311

    Reg #: 9614673 · FEI: 3003559576 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    HITACHI HIGH-TECH CORP., NAKA DIVISION
    Registration Number
    9614673
    FEI Number
    3003559576
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    882 ICHIGE
    City
    Hitachinaka-shi Ibaraki
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K060373

    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
    Electrode, Ion Specific, Potassium CEM
    Electrode, Ion Specific, Sodium JGS
    Electrode, Ion-Specific, Chloride CGZ

    Proprietary Names

    c311 cobas 6000 Series System (c501 and e601 Module)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)