SYNEK MED

SYNEK Med specialises in disposable bed mats designed for healthcare and homecare settings. These products are intended to serve as protective and hygienic barriers for patient care, reducing contamination risks in clinical and residential environments. The devices are non-invasive and classified under Class I, indicating they pose minimal risk.

SYNEK Med is based in Romania, where it operates under European Union regulatory standards. Since its devices fall under Class I—low-risk, non-invasive medical devices—they are subject to EU requirements, including registration in the EUDAMED database. This ensures compliance with EU medical device regulations without needing additional national approvals.

Yes, SYNEK Med’s products are registered in the EUDAMED database, which is the official EU registry for medical devices. This listing confirms the company’s compliance with EU regulatory requirements for Class I devices, ensuring transparency and traceability for healthcare providers and authorities.

SYNEK Med’s devices are classified as Class I medical devices. This classification applies because they are low-risk, non-invasive products—specifically disposable bed mats—intended for single-use in healthcare and homecare settings. Class I devices require conformity assessment procedures, including manufacturer declarations, but do not typically need third-party involvement unless additional safety features are incorporated.