BioGnost Ltd.

BioGnost Ltd. specializes in laboratory reagents and diagnostic kits primarily used in histopathology, hematology, cytology, transfusiology, and microbiology. Their products include staining solutions like hematoxylin (Weigert A and H), cytology reagents such as methylene blue and Loeffler’s reagent, microbiology reagents like Papa’s reagens (EA 50 and OG-EA31 variants), mounting media (e.g., Myco-Mount Red), and hematology test kits (e.g., acetylcholinesterase rapid kits). These items are designed for use in clinical and diagnostic laboratory settings.

BioGnost Ltd. is based in Croatia (HR). Their medical devices are classified under Class A according to European Union regulations, which applies to low-risk products like laboratory reagents and diagnostic kits. Since these devices fall under Class A, they are subject to the EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) where applicable, ensuring compliance with European regulatory requirements for safety and performance.

Yes, BioGnost Ltd.’s devices are registered in the EUDAMED database, which is the European Union’s transparency database for medical devices. This registration allows healthcare professionals, regulators, and other stakeholders to verify the manufacturer’s details and device information, ensuring traceability and compliance with EU regulatory requirements.

All of BioGnost Ltd.’s listed devices fall under Class A classification in the European Union. This classification applies to low-risk medical devices, such as laboratory reagents, stains, and diagnostic kits, which pose minimal risk to patients or users. Class A devices typically require basic conformity assessment procedures, including self-certification by the manufacturer, to demonstrate compliance with essential safety and performance requirements.