BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    HITACHI HIGH-TECH CORP., Ome Works

    Reg #: 9610865 · FEI: 3002806350 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    27
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    HITACHI HIGH-TECH CORP., Ome Works
    Registration Number
    9610865
    FEI Number
    3002806350
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3-7-19, Imai
    City
    Ome-Shi Tokyo
    Country
    JP

    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
    Automated Occult Blood Analyzer OOX
    Calculator/Data Processing Module, For Clinical Use JQP
    System, Test, Radioallergosorbent (Rast) Immunological DHB

    Proprietary Names

    CCM Vertical Elevator Unit CCM Vertical Overhead Conveyor Unit (1m) Modular Pre-Analytics cobas 8100 automated workflow series CONVEYOR 3 Unit Modular Connection Unit Linear Buffer Unit OUTPUT UNIT Cobas 6000 Connection Unit Add-On Buffer Unit CCM Backend Connection Unit CCM Vertical Turntable Unit Cobas 8000 Connection Unit CCM Vertical Power Box Unit CONVEYOR 1 Unit CCM Address Extension Unit Power Supply Unit CONVEYOR 2 Unit CCM Bidirectional Interface Turn Unit HST Connection Unit CCM cobas c513 Connection Unit CONVEYOR 4 Unit Phadia 5000 Phadia 250 Phadia 1000 Phadia 2500

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)