BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    cobas 8100 automated workflow series

    Reg #: 3031570369 · FEI: 3031570369 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HITACHI HIGH-TECH CORP., Musashimurayama Center
    Registration Number
    3031570369
    FEI Number
    3031570369
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1-26-37 Inadaira
    City
    Musashimurayama 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
    Calculator/Data Processing Module, For Clinical Use JQP

    Proprietary Names

    cobas 8100 automated workflow series Modular Pre-Analytics CCM cobas c513 Connection Unit CCM Bidirectional Interface Add-On Buffer Unit Cobas 8000 Connection Unit Turn Unit Power Supply Unit Cobas 6000 Connection Unit HST Connection Unit CCM Address Extension Unit CONVEYOR 2 Unit Modular Connection Unit Linear Buffer Unit CONVEYOR 3 Unit CONVEYOR 1 Unit CCM Backend Connection Unit CONVEYOR 4 Unit OUTPUT UNIT

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)