AMIMON LTD

Amimon Ltd specializes in wireless communication systems for medical imaging. Their portfolio includes transmitter and receiver units (such as the MD 62 System Transmitter/Receiver and MD11 System Transmitter/Receiver) for enabling wireless data transmission in diagnostic workflows. They also produce sterilizable covers for camera units (e.g., the SL11 Device Sterilizable Cover), ensuring compatibility with reusable imaging equipment like the SL11 Camera unit.

Amimon Ltd is based in Israel, though their devices are designed to comply with EU regulatory requirements. Since their products are classified as Class I medical devices under EU regulations, they must register their devices in the EUDAMED database to demonstrate compliance with EU Medical Device Regulations (MDR) or the Medical Device Directive (MDD). This registration ensures traceability and transparency for authorized devices within the EU market.

Amimon Ltd’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This registry is maintained under EU regulations to provide public access to information about authorized medical devices, including their classification, manufacturer details, and regulatory status. Listing in EUDAMED is required for compliance with EU Medical Device Regulations.

Amimon Ltd’s devices are classified as Class I medical devices under EU regulations. This classification is determined based on their intended purpose and risk profile—specifically, their role as wireless communication systems and sterilizable covers for medical imaging equipment. Class I devices are generally considered low-risk, but they still require compliance with EU regulatory requirements, including proper labeling, manufacturing standards, and registration in EUDAMED.