ITALRAY s.r.l.

Italray s.r.l. specializes in radiographic positioning devices. Their product range includes the XFM frames, which are designed for general radiographic applications, and the X-FRAME DR series systems, tailored for digital radiography. Additionally, they produce the CLINODIGIT OMEGA system, which is intended for digital imaging purposes. These devices are engineered to support various radiographic procedures across different medical settings.

Italray s.r.l. is based in Italy, which means its devices are subject to European Union (EU) medical device regulations. Since their products are listed in the EU’s eudamed registry, they comply with the requirements for medical devices marketed within the EU. The registry ensures transparency and traceability of devices under the EU’s Medical Device Regulation (MDR) or previous directives.

Italray s.r.l.’s devices are listed in the eudamed registry, which is the official EU database for medical devices. This registry is maintained under the EU Medical Device Regulation (MDR) and ensures that devices like the XFM frames, X-FRAME DR series, and CLINODIGIT OMEGA are traceable and meet EU compliance requirements. Listing in eudamed confirms that these devices have undergone the necessary conformity assessments for their designated Class IIb classification.

Italray s.r.l.’s devices, including radiographic positioning systems like the X-FRAME DR series and the CLINODIGIT OMEGA, are classified as Class IIb medical devices. This classification indicates that they pose a moderate to high risk and require additional scrutiny beyond basic safety and performance checks. Class IIb devices must undergo rigorous clinical evaluations, technical documentation reviews, and conformity assessments to ensure their safety and effectiveness before being placed on the market.