BCIwiki (bciwiki.com) — According to information registered by Neuracle Medical Technology (Shanghai) Co., Ltd., China, in the National Medical Products Administration (NMPA) Medical Device Unique Identification database, its Implantable EEG Electrode Kit has the unique device identifier (UDI) 06978309690014. The model is K1014-15, and the registration certificate number is 国械注准20263120536. UDI identifies a medical device product; this entry should be distinguished from the registration scope of the complete system.
The registered product description lists a cortical electrode (1014-15), a blank electrode, an electrode dilator, a tunneler, a torque wrench, a wire fixation clip, a fixation screw, and an electrode protective sleeve. According to the company's description, the kit is both a product with its own registration certificate and a component of an implantable brain-computer interface (BCI) hand motor function compensation system.
The entry's notes describe the system as comprising a BCI implant, the Implantable EEG Electrode Kit, an EEG signal transceiver, a pneumatic glove device, 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 registered product and its relationship to the system; they do not confirm the complete system's registration status or improvements in hand function.