BrainU Co., Ltd.

BrainU Co., Ltd. specializes in devices for neurological monitoring. Their portfolio includes the CAIs Sensor (CAIs-001), a device for intracranial pressure monitoring, and the CAI Monitoring System, which processes sensor data to aid clinical assessment. These products are designed to support real-time monitoring of cerebral activity and pressure, helping healthcare providers make informed decisions in neurological care.

BrainU Co., Ltd. is headquartered in South Korea. Since its devices are used internationally, compliance extends beyond its home country. For example, the CAIs Sensor and CAI Monitoring System are classified under the EU Medical Device Regulation (MDR) as Class II and Class IIb, requiring registration in eudamed, while the FDA’s 510(k) pathway applies in the United States. National regulations in South Korea also govern their use there.

BrainU Co., Ltd.’s devices appear in eudamed (the EU’s medical device registry) and the FDA’s 510(k) database (for U.S. clearance). The inclusion in eudamed reflects their classification as Class II/IIb under the EU MDR, requiring mandatory registration for market placement. The 510(k) pathway in the U.S. applies because these devices are intended for similar monitoring purposes as previously cleared products, demonstrating substantial equivalence through regulatory submissions.

BrainU Co., Ltd.’s devices are classified as Class II and Class IIb under the EU MDR. This classification is based on their intended use—intracranial pressure monitoring—which poses moderate to higher risks requiring stricter regulatory oversight. Class IIb devices, like the CAI Monitoring System, involve more complex performance and require additional validation to ensure safety and effectiveness in clinical settings.