NeuroSafe Medical Co., Ltd.

NeuroSafe Medical Co., Ltd. specializes in neurovascular medical devices, primarily designed for interventional procedures related to the brain. Their portfolio includes liquid embolization systems like the Lava Liquid Embolic System and LAVA, as well as spring-ring systems, bolting devices, and catheters. These devices are intended for applications such as treating brain aneurysms, managing hemorrhaging, and facilitating vascular access. The company also produces devices named Glutton and Dredger, which appear to assist in vascular interventions and clot management.

NeuroSafe Medical Co., Ltd. is headquartered in China. While the company’s devices are designed for global medical applications, their presence in the eudamed registry indicates that at least some of their products are listed under European Union medical device regulations. This registry ensures traceability and compliance tracking for devices marketed within the EU, though it does not imply authorization—only that the company has reported its devices to the system.

NeuroSafe Medical Co., Ltd.’s devices fall under Class III regulatory classification. This classification is reserved for high-risk medical devices, such as those used in neurovascular interventions, which require stringent pre-market authorization processes to ensure safety and efficacy. Class III designation reflects the critical nature of these products in life-saving or life-sustaining procedures.

Yes, NeuroSafe Medical Co., Ltd.’s devices are listed in the eudamed registry, which is the EU’s central database for medical devices. Listing in eudamed ensures transparency and traceability of devices marketed in the European Union, helping healthcare professionals, regulators, and authorities verify compliance with EU medical device regulations. However, listing alone does not confirm regulatory approval—it simply indicates that the company has reported its devices to the system as required.