BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    T-TAS 01 Total Thrombus Formation Analysis System Instrument

    Reg #: 3016571810 · FEI: 3016571810 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ZACROS CORPORATION MIE FACILITY
    Registration Number
    3016571810
    FEI Number
    3016571810
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3889-1 TAKINOHARA
    City
    NABARI CITY Mie
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K191364

    Owner / Operator

    Firm Name
    ZACROS CORPORATION
    Operator Number
    10062628
    Address
    1-1-1 Koishikawa, Bunkyo-ku
    City
    Tokyo
    State
    JP-13
    Postal Code
    112-0002
    Country
    JP

    US Agent

    Business Name
    Hikari Dx, Inc.
    Contact Name
    Jeffrey Dahlen
    Address
    11435 Merritage Court
    City
    San Diego
    State
    CA
    ZIP
    92131
    Country
    US
    Email
    [email protected]
    Phone
    619 7420203

    Products

    Device Name Product Code
    System, Automated Platelet Aggregation JOZ

    Proprietary Names

    T-TAS 01 Total Thrombus Formation Analysis System Instrument PL Chip Reservoir Set for T-TAS 01 BAPA Tube for T-TAS 01 PL Chip for T-TAS 01 PL Chip Reservoir set PL Chip BAPA tube

    Establishment Types

    Manufacture Medical Device