BIOLAN MICROBIOSENSORES S.L.

Biolan Microbiosensors S.L. specializes in reactive test strips, control kits, and rapid diagnostic devices primarily for infectious disease detection. Their portfolio includes lateral flow assays such as COVID-19 antigen and antibody tests, as well as glucose monitoring strips and control solutions. These devices are designed for both professional use in laboratories and self-testing in home or community settings, ensuring accessibility and ease of use.

Biolan Microbiosensors S.L. is based in Spain, which places its devices under the jurisdiction of the European Union’s In Vitro Diagnostic Regulation (IVDR). Since the company operates within the EU, its products must comply with IVDR requirements, including classification under either Class A or Class IVD (In Vitro Diagnostics) categories, and registration in the EU’s eudamed database to ensure traceability and regulatory transparency.

Biolan Microbiosensors S.L.’s devices are listed in the eudamed registry, the official EU database for in vitro diagnostic medical devices. This listing is critical because it confirms compliance with EU regulations, ensures traceability of devices in the market, and provides transparency for healthcare professionals, regulators, and patients. It also helps streamline audits and market surveillance processes under the IVDR framework.

Biolan Microbiosensors S.L.’s devices are classified as either Class A (low-risk diagnostics) or IVD General/self-testing categories under the EU’s In Vitro Diagnostic Regulation (IVDR). This classification determines the level of scrutiny and regulatory requirements they face—Class A devices typically undergo less stringent evaluation than higher-risk devices, while self-testing devices must meet additional safety and usability standards to ensure reliability when used by individuals without professional medical oversight.