BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    TCOAG IRELAND LIMITED

    Reg #: 3008386529 · FEI: 3008386529 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    47
    Establishment Types
    3
    Classifications
    15

    Registration Details

    Registration Name
    TCOAG IRELAND LIMITED
    Registration Number
    3008386529
    FEI Number
    3008386529
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    IDA BUSINESS PARK, SOUTHERN CROSS ROAD
    City
    BRAY Wicklow
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K893524

    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
    Plasma, Coagulation Factor Deficient GJT
    Test, Time, Prothrombin GJS
    Reagent & Control, Partial Thromboplastin Time GIT
    General Purpose Reagent PPM
    System, Fibrinogen Determination KQJ
    Activated Partial Thromboplastin GFO
    Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control DAP
    Control, Plasma, Abnormal GGC
    Multi-Analyte Controls Unassayed OHQ
    Test, Qualitative And Quantitative Factor Deficiency GGP
    Antithrombin Iii Quantitation JBQ
    Plasma, Coagulation Control GGN
    Reagent, Russel Viper Venom GIR
    Reagent, Platelet Aggregation GHR
    System, Multipurpose For In Vitro Coagulation Studies JPA

    Proprietary Names

    TriniCLOT Factor IX TriniCLOT PT Excel S 10 x 6ml TriniCLOT PT Excel S 5 x 20ml TriniCLOT aPTT HS 10 x 10ml TriniCLOT aPTT HS 10 x 3ml TriniCLOT Factor XI TriniCLOT Factor V DT Wash (DTW) DT Fluid (DTF) STA - Cleaner Solution (00973) STA - Desorb U (00975) TriniCAL Fibrinogen TriniCLOT Imidazole Buffer TriniCLOT Fibrinogen Kit TriniCLOT Automated aPTT 3ml TriniCLOT Automated aPTT 6ml TriniCHECK D-Dimer 3 D-Dimer Control Level 3 TriniCHECK Abnormal control TriniCHECK Level 1 TriniCHECK Level 2 TriniCHECK Level 3 TriniCHROM Factor VIII: C TriniCLOT aPTT S 5 x 10ml TriniCLOT aPTT S 5 x 3ml TriniCLOT Factor VII TriniCLOT Factor VIII D-Dimer Control Level 2 TriniCHECK D-Dimer 2 TriniCHROM Antithrombin IIa TriniCAL Reference Plasma TriniCLOT Factor II Accuclot DRVVT Confirm TriniCLOT Lupus Confirm Ristocetin TriniCLOT Factor XII TriniCLOT Factor X TriniCLOT Lupus Screen Accuclot DRVVT Screen TriniCLOT Calcium Chloride (025M) TriniCLOT Thrombin 10 x 4ml TriniCLOT Thrombin 10 x 1ml TriniLIZE PAI-1 Antigen TriniLIZE PAI-1 Activity TriniLIA D-Dimer Auto D-Dimer Kit Auto D-Dimer Calibrator

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility