BCIwiki (bciwiki.com) — According to information listed by Neuracle Medical Technology (Shanghai) Co., Ltd. in China's National Medical Products Administration (NMPA) medical device unique identification database, its Implantable EEG Electrode Kit is Model K1014-15. The unique device identifier (UDI) is 06978309690939, and the registration certificate number shown is 国械注准20263120537.
The product description lists a cortical electrode (1014-15), a blank electrode, an electrode expander, a tunneler, a torque wrench, a wire fixation clip, fixation screws, and an electrode protective sleeve as the kit's components. The kit is one component of an implantable brain-computer interface (BCI) hand motor function compensation system, rather than the complete system.
The entry's remarks describe the complete system as comprising a BCI implant, the implantable EEG electrode kit, an EEG transceiver, pneumatic glove equipment, a disposable surgical tool kit, EEG decoding software, medical testing software, and clinical management software. All three software products have release version 1.0. These details describe the listed product and system composition; UDI listing itself does not represent a new marketing authorization or clinical validation of safety or effectiveness.