Manufacturer

Tcoag

IrelandLegal entities : Tcoag ireland ltd

Markets : Austria · Belgium · Denmark · Finland · France · Germany · Ireland · Netherlands · Spain · United States

Approvals : EU – class A, B · United States (FDA) – · class I, II

27 categories, 60 models including 60 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Control plasma for haemostasis	W0103020702	TriniCHECK Abnormal control98/79 TriniCHECK Control 1 (Assayed)98/79 TriniCHECK Control 2 (Assayed)98/79 TriniCHECK D-Dimer 298/79 TriniCHECK D-Dimer 398/79 4 others TriniCHECK Level 198/79 TriniCHECK Level 298/79 TriniCHECK Level 398/79 TriniCHECK LIA Control Set98/79	– 98/79	EUDAMED record Report an error
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)	W0103010105	sthemA CL-15 sthemA CL-250 sthemA DL-2500 sthemA DL-9000 sthemA FD-50 3 others sthemA FL-50 sthemA HB-250 sthemA WB-250	A IVDR	EUDAMED record Report an error
Activated partial thromboplastin time	W0103020102	TriniCLOT aPTT HS 10 mL98/79 TriniCLOT aPTT HS 3 mL98/79 TriniCLOT APTT S 10ML98/79 TriniCLOT aPTT S 5 mL98/79 TriniCLOT Automated aPTT 6 mL98/79	– 98/79	EUDAMED record Report an error
IVD instruments - other	W0299	Destiny Max98/79 Destiny Plus98/79 DT 10098/79 KC 4 Delta KC1 Delta98/79	A IVDR, 98/79	EUDAMED record Report an error
Calibration plasma for haemostasis	W0103020701	TriniCAL Fibrinogen98/79 TriniCAL PC/PS98/79 TriniCAL Reference Plasma98/79	– 98/79	EUDAMED record Report an error
Auxiliary reagents (haemostasis) - other	W0103020999	DT Fluid DT Wash	A IVDR	EUDAMED record Report an error
Buffers (haemostasis)	W0103020903	TriniCLOT Imidazole Buffer98/79 TriniCLOT Owrens Buffer	A IVDR, 98/79	EUDAMED record Report an error
Coagulation factor viii	W0103020207	TriniCHROM Factor VIII:C TriniCLOT Factor VIII98/79	B IVDR, 98/79	EUDAMED record Report an error
D-dimer	W0103020503	TriniLIA D-dimer98/79 TriniLIA D-Dimer II98/79	– 98/79	EUDAMED record Report an error
Fibrinogen assays (factor i)	W0103020201	TriniCLOT Fibrinogen 6 mL98/79 TriniCLOT Fibrinogen Kit98/79	– 98/79	EUDAMED record Report an error
Lupus anticoagulant	W0103020606	TriniCLOT Lupus Confirm98/79 W010302060698/79	– 98/79	EUDAMED record Report an error
Prothrombin time ( quick test )	W0103020101	TriniCLOT PT Excel S 20 mL98/79 TriniCLOT PT Excel S 6ml98/79	– 98/79	EUDAMED record Report an error
Thrombin time / reptilase / batroxobin time	W0103020103	TriniCLOT Thrombin Time 1ml98/79 TriniCLOT Thrombin Time 4ml98/79	– 98/79	EUDAMED record Report an error
Aggregation reagents	W0103020401	Ristocetin	B IVDR	EUDAMED record Report an error
Antithrombin	W0103020602	TriniCHROM Antithrombin IIa98/79	– 98/79	EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)	W0202010101	sthemA 601 (Quark) and Autoloader98/79	– 98/79	EUDAMED record Report an error
Calcium chloride	W0103020901	TriniCLOT Calcium Chloride 0.025M98/79	– 98/79	EUDAMED record Report an error
Coagulation factor II ( prothrombin )	W0103020202	TriniCLOT Factor II98/79	– 98/79	EUDAMED record Report an error
Coagulation factor ix	W0103020208	TriniCLOT Factor IX98/79	– 98/79	EUDAMED record Report an error
Coagulation factor v	W0103020204	TriniCLOT aPTT S 5 mL98/79	– 98/79	EUDAMED record Report an error
Coagulation factor vii	W0103020205	TriniCLOT Factor VII98/79	– 98/79	EUDAMED record Report an error
Coagulation factor X	W0103020209	TriniCLOT Factor X98/79	– 98/79	EUDAMED record Report an error
Coagulation factor xi	W0103020210	TriniCLOT Factor XI98/79	– 98/79	EUDAMED record Report an error
Coagulation factor xii	W0103020211	TriniCLOT Factor XII98/79	– 98/79	EUDAMED record Report an error
Protein c	W0103020607	TriniCLOT PC II98/79	– 98/79	EUDAMED record Report an error
Protein s activity	W0103020608	TriniCLOT PS II98/79	– 98/79	EUDAMED record Report an error
Samples analyses, plastic cuvettes	W0503010203	Destiny Cuvette Trays2 refs	A IVDR	EUDAMED record Report an error

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