The registration states that the implantable EEG electrode kit holds its own registration certificate and is also a component of an implantable BCI hand motor function compensation system. That system consists of a BCI implant, the implantable EEG electrode kit, an EEG signal transceiver, a pneumatic glove, a single-use surgical toolkit, and three software packages: EEG decoding software (release 1.0), medical testing software (release 1.0) and clinical management software (release 1.0). The cortical electrode was registered on September 10, 2026.
Neuracle Registers Cortical Electrode in China's NMPA Device Identifier Database
Summary
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.
Why it matters
What was registered is not a complete BCI but a single cortical electrode, and the detail that matters is that its electrode kit is certified in its own right while also forming part of the implantable hand motor function compensation system, indicating the system is going through registration component by component; how complete its parts list is (implant, electrode kit, signal transceiver, pneumatic glove and three software packages) is a direct clue to how far it is from clinical use.
Compiled by BCIwiki from public sources
Sources · 1
udi.nmpa.gov.cn 2026-09-10