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 Cortical Electrode is Model 1014-15. The unique device identifier (UDI) is 06978309690960, and the registration certificate number shown is 国械注准20263120537.
The product description identifies the cortical electrode (1014-15) as a component of an implantable EEG electrode kit. The kit also includes a blank electrode, an electrode expander, a tunneler, a torque wrench, a wire fixation clip, fixation screws, and an electrode protective sleeve. The kit is itself a component of an implantable brain-computer interface (BCI) hand motor function compensation 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 product and system composition; UDI listing itself does not represent a new marketing authorization or clinical validation of safety or effectiveness.