SBM SISTEMI SRL

SBM Sistemi S.R.L. specializes in ophthalmic diagnostic devices. Their portfolio includes corneal topography systems like the TDEX, OS1000X, ES600, and ES600X, which map the eye’s surface curvature for clinical assessment. They also produce devices for tear film analysis (e.g., TFA, TFA-2), intraocular pressure measurement (IDRA), anterior segment imaging (OSA), and corneal topography (GAUSH IDEA). Additionally, they offer hardware platforms like the SBM Devices Base, designed to integrate with these diagnostic tools.

SBM Sistemi S.R.L. is headquartered in Italy, which places its devices under the jurisdiction of the European Union’s Medical Device Regulations (MDR). Since their products fall under Class I and Class IIa classifications, they must comply with EU requirements, including registration in the EUDAMED database—a centralized EU system for tracking medical devices. This ensures transparency and traceability of their products within the European market.

SBM Sistemi S.R.L.’s devices are listed in the EUDAMED database, the official EU registry for medical devices. This registry is critical because it provides authorized regulators, healthcare professionals, and patients with verified information about the devices’ classification, manufacturer details, and compliance status under EU Medical Device Regulations. Listing in EUDAMED ensures transparency and facilitates market surveillance.

SBM Sistemi S.R.L.’s devices are classified as Class I (low-risk, non-invasive diagnostic tools like some corneal topography systems) and Class IIa (moderate-risk devices, such as intraocular pressure measurement or advanced imaging systems). This classification determines the regulatory scrutiny and technical documentation required. Class IIa devices, for example, must undergo additional risk assessments and conformity evaluations to ensure safety and performance before entering the market.

SBM Sistemi S.R.L. offers the SBM Devices Base, a compact hardware platform designed to support their diagnostic imaging and measurement solutions. This platform includes high-performance specifications like an Intel® Core™ i7 processor, 16GB RAM, and Windows 11 PRO, ensuring compatibility and seamless operation with devices such as corneal topography systems or tear film analyzers. The plug-and-play design simplifies setup and enhances the functionality of their diagnostic tools.