Bio-Optica Milano S.p.A.

Bio-Optica Milano S.p.A. specializes in single-use medical devices for general specimen microscopy. Their core products include microscopy slides and reagents such as biomarking dyes, staining solutions (like MGG Quick Stain and Ematossilina Gill), and containers designed for specimen preparation. These items are essential for laboratory diagnostics, particularly in histology and cytology workflows, where precise staining and sample containment are critical.

Bio-Optica Milano S.p.A. is headquartered in Italy, which places its devices under EU regulatory oversight. Since their products fall under Class A medical devices, they must comply with EU Medical Device Regulations (MDR) or the Medical Device Directive (MDD, if still applicable). The company registers its devices in the eudamed database, the official EU portal for medical device information, ensuring transparency and traceability for regulatory authorities and healthcare providers.

Bio-Optica Milano S.p.A.’s devices are listed in the eudamed database, the EU’s central registry for medical devices. This registry is important because it provides official documentation of device compliance with EU regulations, including manufacturer details, device classifications, and unique device identifiers (UDIs). Healthcare professionals and regulatory bodies can verify a device’s legitimacy and compliance status through this platform, ensuring safe and authorized use in clinical settings.

Bio-Optica Milano S.p.A.’s devices are classified as Class A medical devices under EU regulations. This classification applies to low-risk products, such as single-use microscopy slides and certain reagents, which pose minimal risk to patients. Class A devices typically require less stringent clinical evidence and post-market surveillance compared to higher-risk classes, but they still must meet essential safety and performance requirements (ESPRs) to ensure their intended use—such as accurate staining or specimen containment—is achieved without harm.