LEVMED LTD

LevMed Ltd specializes in reusable electrocardiographic (ECG) electrodes. Their products include 12-lead ECG electrode belts, limb electrodes, pediatric-specific ECG belts, and universal belts with straps or handles. These devices are designed to interface with various ECG monitoring systems, including those requiring Schiller or EDAN connectors, as well as broader-compatible universal belts.

LevMed Ltd is headquartered in Israel. The company’s location is relevant for understanding its regulatory context, particularly for devices marketed in the EU or under FDA oversight.

LevMed Ltd’s devices are listed in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. These registries track medical devices for transparency and compliance purposes, ensuring traceability for both regulatory authorities and healthcare providers.

LevMed Ltd’s ECG electrodes are classified as Class I or Class II devices. Classification determines regulatory requirements—Class I devices typically pose minimal risk and require fewer controls, while Class II devices may involve moderate risk (e.g., performance standards or post-market surveillance). The specific classification depends on factors like design, intended use, and potential risks outlined in regulatory guidelines.