BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    HITACHI HIGH-TECH CORP., Ome Works

    Reg #: 9610865 · FEI: 3002806350 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HITACHI HIGH-TECH CORP., Ome Works
    Registration Number
    9610865
    FEI Number
    3002806350
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3-7-19, Imai
    City
    Ome-Shi Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K092330

    Owner / Operator

    Firm Name
    Hitachi, Ltd.
    Operator Number
    8030222
    Address
    1-17-1, Toranomon
    City
    Minato-ku
    State
    Tokyo
    Postal Code
    105-6412
    Country
    JP
    Correspondent
    Yuko Tamura

    Products

    Device Name Product Code
    Automated Occult Blood Analyzer OOX

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)