Eclipse Medical Co. Ltd

Eclipse Medical Co. Ltd specializes in two main categories of devices: left atrial appendage (LAA) occlusion devices and vascular plugs. The OMEGA LAA Occluder is designed to close the LAA, a common treatment for reducing stroke risk in patients with atrial fibrillation. The ChekFLO brand includes vascular plugs used for embolization or occlusion in blood vessels, available in multiple sizes to suit different clinical needs.

Eclipse Medical Co. Ltd is headquartered in Thailand. The company’s location influences its regulatory compliance framework, particularly for devices marketed in the European Union, where EU regulations apply.

Eclipse Medical Co. Ltd’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This registry ensures transparency and traceability of devices authorized under EU regulations, such as Class IIb and Class III classifications.

Eclipse Medical Co. Ltd’s devices fall into two EU risk classes: Class III and Class IIb. Class III devices, like the OMEGA LAA Occluder, are high-risk and require rigorous clinical evaluation due to their potential impact on patient safety. Class IIb devices, such as the ChekFLO vascular plugs, are moderate-risk and undergo stringent design controls and performance testing to ensure safety and effectiveness.