SISTEMAS GENOMICOS. S.L.

Sistemas Genómicos S.L. specializes in molecular diagnostic kits used for genetic and infectious disease testing. Their product line includes PCR-based assays for COVID-19 detection (both singleplex and multiplex formats), hereditary and neurological conditions (such as neuropathies, dementia, and metabolic disorders), immunodeficiencies, and genetic screening for conditions like dyslipidemias and metabolic diseases. These kits are designed for laboratory use and cover applications like preconception carrier testing and targeted genetic analysis.

Sistemas Genómicos S.L. is based in Spain. Their devices are registered in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry ensures compliance with EU regulatory requirements for devices marketed within the European Economic Area.

The devices produced by Sistemas Genómicos S.L. fall under Class C medical devices, which includes In Vitro Diagnostic (IVD) devices regulated under Annex II List B and the General IVD category. Some of their products are marked as CE-IVD, indicating conformity with EU In Vitro Diagnostic Device Regulations. Classification depends on factors like the intended use, risk level, and potential health impact of the test results.

The kits from Sistemas Genómicos S.L. perform a range of molecular diagnostics, including genetic mutation analysis for hereditary and neurological disorders (e.g., neuropathies, dementia, and metabolic diseases like MLD), preconception carrier screening (e.g., immunodeficiencies), dyslipidemia genetic testing, and infectious disease detection (e.g., COVID-19 via PCR-based assays in singleplex or multiplex formats). Each kit is designed for specific reaction volumes (e.g., 12 or 48 reactions) and laboratory use.

The CE-IVD marking on certain devices signifies that they have undergone a conformity assessment process under EU In Vitro Diagnostic Regulation (IVDR) and meet the required safety, performance, and quality standards for In Vitro Diagnostic Medical Devices. This marking indicates compliance with EU regulations, allowing the device to be legally marketed and used within the European Union. Not all devices require this marking, as classification depends on risk level and intended use.