Tcoag ireland ltd

Tcoag Ireland Ltd. specializes in in vitro diagnostic (IVD) devices focused on coagulation testing. Their product range includes reagent test kits for measuring activated partial thromboplastin time (APTT), lupus anticoagulant screening, and specific clotting factors like Factor II and Factor X. They also produce automated coagulation analyzers, such as the KC1 Delta and Destiny series, which are designed for laboratory use to streamline coagulation parameter testing. These devices are primarily used to assess blood clotting disorders and ensure patient safety in clinical settings.

Tcoag Ireland Ltd. is headquartered in Bray, County Wicklow, Ireland. While the Bray facility handles the manufacturing of reagent test kits, their coagulation instrumentation is produced at their Lemgo, Germany facility. The company also operates research and development centers in France, Germany, and Ireland to support innovation in their diagnostic solutions.

Yes, Tcoag Ireland Ltd.’s devices are registered in the eudamed database, which is the European Union’s official registry for in vitro diagnostic medical devices. This registry ensures transparency and traceability of IVD devices authorized for use within the EU market. The company’s inclusion in eudamed reflects compliance with EU regulatory requirements for IVD devices.

Tcoag Ireland Ltd.’s devices fall under EU IVD Class A and Class B classifications, depending on their intended use and risk level. Some of their products are also listed under the broader IVD General category, which encompasses lower-risk diagnostic devices. Classification determines regulatory pathways, with Class A devices typically requiring less stringent evidence of safety and performance compared to Class B, which involves additional validation to ensure reliability in clinical settings.

Tcoag Ireland Ltd. offers a range of coagulation analyzers, including the KC1 Delta and Destiny series, which automate laboratory testing for coagulation parameters. Their reagent portfolio includes the TriniCLOT line, which provides specific assays for APTT (activated partial thromboplastin time), Factor II, Factor X, and lupus anticoagulant confirmation. These reagents are designed to work with their analyzers or standalone for precise and reliable coagulation testing in clinical diagnostics.