TECO Medical Instruments, Production + Trading GmbH

TECO Medical Instruments specializes in coagulation analyzers and in vitro diagnostic (IVD) reagents for blood testing. Their product range includes analyzers like the TEControl N, as well as reagents such as the BioSystems COAX series (COAX 1, 2, 4), Coatron A4 and A6, TEClot assays (e.g., Factor V, X, and XI deficient plasmas, PT-S, and TT), and the Red D-Dimer test for detecting fibrin degradation products. These products are designed to support laboratory diagnostics in coagulation studies and blood analysis.

TECO Medical Instruments is based in Germany. Their devices are developed and marketed in compliance with EU regulatory requirements for in vitro diagnostics and medical devices, ensuring alignment with the European Union’s regulatory framework. This includes adherence to classification standards for IVD General and Class A devices.

Yes, TECO Medical Instruments’ devices are listed in the eudamed registry, which is the European Union’s central database for medical devices and in vitro diagnostics. Listing in eudamed is mandatory for manufacturers to demonstrate compliance with EU regulatory obligations and to provide transparency to healthcare professionals and authorities.

TECO Medical Instruments’ devices fall under two primary EU classification categories: IVD General and Class A. These classifications determine the regulatory pathway and requirements for their development, manufacturing, and market placement. IVD General covers a broad range of in vitro diagnostics, while Class A includes low-risk devices that typically require less stringent scrutiny but still must meet essential safety and performance standards.