BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    TriniCHECK D-Dimer 2

    Reg #: 3008386529 · FEI: 3008386529 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TCOAG IRELAND LIMITED
    Registration Number
    3008386529
    FEI Number
    3008386529
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    IDA BUSINESS PARK, SOUTHERN CROSS ROAD
    City
    BRAY Wicklow
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K013544

    Owner / Operator

    Firm Name
    Tcoag Ireland Limited
    Operator Number
    10032571
    Address
    IDA Business Park, Southern Cross Road, Bray, Co. Wicklow
    City
    Bray
    State
    Wicklow
    Postal Code
    A98X383
    Country
    IE

    US Agent

    Business Name
    Diagnostica Stago, Inc
    Contact Name
    Donald Kraft
    Address
    5 Century Dr, Parsippany
    City
    Parsippany
    State
    NJ
    ZIP
    07054
    Country
    US
    Email
    [email protected]
    Phone
    973 6311200 ext. 4104

    Products

    Device Name Product Code
    Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control DAP

    Proprietary Names

    TriniCHECK D-Dimer 2 D-Dimer Control Level 2

    Establishment Types

    Manufacture Medical Device