"Bio-Ksel" Sp. z o.o.

Bio-Ksel Sp. z o.o. specializes in automated coagulation analyzers, which are used in laboratory settings for blood coagulation testing. Their portfolio includes systems like the bioksel 6100, a comprehensive analyzer for routine hematology diagnostics, and the Bio-Ksel PT plus, a dedicated prothrombin time (PT) analyzer. These devices are designed to assist in diagnosing and monitoring blood clotting disorders.

Bio-Ksel Sp. z o.o. is based in Poland, which places its devices under the regulatory jurisdiction of the European Union. Since their products fall under the In Vitro Diagnostic Regulation (IVDR), they must comply with EU requirements and are registered in the EUDAMED database, ensuring transparency and traceability of their medical devices within the EU market.

Bio-Ksel’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This registry is maintained under the In Vitro Diagnostic Regulation (IVDR) framework, ensuring that their coagulation analyzers and IVD reagents are documented for compliance and market surveillance purposes.

Bio-Ksel’s devices are classified as Class A coagulation analyzers and IVD General reagents. This classification is determined by their intended use and risk level, with Class A devices being considered low-risk, while IVD General reagents are subject to specific conformity assessment procedures under the IVDR to ensure their safety and performance in diagnostic applications.