MASMEC SpA

MASMEC SpA manufactures medical imaging devices, including the SIRIO H3, a high-resolution imaging system, and the PRIME MDX, a portable X-ray unit designed for diagnostic radiography. These products are intended for use in clinical settings to capture detailed images of internal structures and support diagnostic evaluations. The portfolio also includes accessories and software tailored for imaging workflows in radiology departments.

The company’s devices are regulated under EU Medical Device Regulations (Class A and Class II) and are listed in the EUDAMED database, with some models also documented in the FDA’s 510(k) clearance registry. MASMEC SpA is headquartered in Italy, where its products are subject to compliance with both European and U.S. regulatory requirements.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.