Neuracle Lists Cortical Electrode in NMPA UDI Database
Neuracle Medical Technology (Shanghai) Co., Ltd. listed its Model 1014-35 cortical electrode in the National Medical Products Administration's medical device unique identification database. The entry identifies the electrode as a component of an implanted EEG electrode kit, which in turn forms part of an implanted BCI hand motor function compensation system. The system also includes a BCI implant, an EEG transceiver, pneumatic glove equipment, and related software. The entry clarifies these component relationships; UDI listing itself is neither a new marketing authorization nor evidence of clinical effectiveness.
Why it matters
The entry concerns the cortical electrode rather than describing the entire system as a single listed item. Distinguishing the electrode, the implanted EEG electrode kit, and the hand function compensation system clarifies what was listed and how it fits into the system.