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 1014-35. The unique device identifier (UDI) is 06978309690984, and the registration certificate number shown in the entry is 国械注准20263120537.
The product description identifies the electrode as a component of an implanted EEG electrode kit. The kit comprises the cortical electrode (1014-35), 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 implanted brain-computer interface (BCI) hand motor function compensation system.
The entry's remarks describe the full system as comprising a BCI implant, the implanted 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 establish the extent of functional improvement in patients.