Neuracle Registers Cortical Electrode in China's NMPA Device Identifier Database
Neuracle Medical Technology (Shanghai) Co., Ltd. has registered a cortical electrode, model 1014-35, in the medical device unique identification (UDI) database of China's National Medical Products Administration (NMPA), under registration certificate Guoxiezhuzhun 20263120536. Neuracle's product line spans EEG acquisition equipment and implantable electrodes. The electrode belongs to an implantable EEG electrode kit (cortical electrode, blank electrode, electrode dilator, tunneler, torque wrench, lead fixation clip, fixation screws and electrode protective sleeve) that holds its own registration certificate and is also a component of an implantable BCI hand motor function compensation system. That system comprises a BCI implant, the electrode kit, an EEG signal transceiver, a pneumatic glove, a single-use surgical toolkit, and three software packages for EEG decoding, medical testing and clinical management.