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 model designation K1014-25. Its unique device identifier (UDI) is 06978309690021, and its registration certificate number is 国械注准20263120536.
The company's product description lists a cortical electrode (1014-25), 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 entry, 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 relationship between the kit and the system; the kit's UDI entry alone does not confirm the complete system's registration status or clinical performance.