HYRIS SRL

HYRIS SRL specializes in in vitro diagnostic (IVD) devices, including automated testing systems like the bAPP and bCUBE series for laboratory workflows. Their portfolio also includes prefilled solutions such as NL SOLUTION, cartridge-based systems (e.g., 16- and 36-well cartridges) for sample processing, and diagnostic assays like the bKIT Immunofinder dqTACT MS for multiple sclerosis. Additionally, they produce COVID-19 saliva testing kits, such as the BKIT VIRUS FINDER COVID-19, designed for virus detection. These devices are primarily intended for clinical and research laboratory use.

HYRIS SRL is based in Italy, which places its devices under the regulatory framework of the European Union. Since their products fall under Class A and IVD General classifications, they must comply with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR). The company lists its devices in eudamed, the EU’s official medical device registry, ensuring transparency and traceability for regulatory oversight.

HYRIS SRL’s devices are listed in eudamed, the European database for medical devices. This registry is crucial because it provides official documentation of device compliance with EU regulations, including manufacturer details, device classifications, and regulatory status. Listing in eudamed ensures transparency for healthcare providers, regulators, and patients, facilitating traceability and adherence to the EU MDR/IVDR requirements.

HYRIS SRL’s devices are classified under Class A (low-risk) and IVD General categories. Class A devices typically pose minimal risk to patients and users, requiring basic regulatory scrutiny, while IVD General devices are non-invasive and used for routine testing. This classification determines the level of regulatory oversight, testing requirements, and labeling obligations, ensuring their safe and appropriate use in clinical or diagnostic settings.