SIDLY SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

SIDLY manufactures wearable wristbands focused on continuous health monitoring. Specifically, their devices include the SiDLY Care PRO and SiDLY VITAL CARE, which are designed to track vital signs and user safety metrics. These products are intended for monitoring health parameters in real-time, supporting proactive health management.

SIDLY is based in Poland. As a manufacturer of medical devices, its products fall under the regulatory framework of the European Union, where they must comply with EU medical device regulations. The company’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices.

SIDLY’s medical devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry ensures transparency and traceability of devices that have undergone the necessary conformity assessment procedures under EU medical device regulations.

SIDLY’s devices, including the SiDLY Care PRO and SiDLY VITAL CARE, are classified as Class IIa under the EU Medical Device Regulation (MDR). This classification is determined based on the risk associated with the device’s intended use and design. Class IIa devices require a higher level of scrutiny than Class I but less than higher-risk classes like IIb or III, ensuring they meet stringent safety and performance standards.