BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    T-TAS 01 Total Thrombus Formation Analysis System Instrument

    Reg #: 1000487132 · FEI: 1000487132 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OEM SYSTEMS CO. LTD.
    Registration Number
    1000487132
    FEI Number
    1000487132
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    84 MEKAWA MAKISHIMA-CHO
    City
    UJI-SHI Kyoto
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K191364

    Owner / Operator

    Firm Name
    OEM SYSTEMS CO. LTD.
    Operator Number
    9050895
    Address
    84 MEKAWA MAKISHIMA-CHO
    City
    UJI-SHI KYOTO
    State
    JP-NOTA
    Postal Code
    6110041
    Country
    JP
    Correspondent
    Kenneth Block

    US Agent

    Business Name
    Ken Block Consulting
    Contact Name
    Kenneth Block
    Address
    800 E Campbell Rd Suite 202
    City
    Richardson
    State
    TX
    ZIP
    75081
    Country
    US
    Email
    [email protected]
    Phone
    972 4809554

    Products

    Device Name Product Code
    System, Automated Platelet Aggregation JOZ

    Proprietary Names

    T-TAS 01 Total Thrombus Formation Analysis System Instrument

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)