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2026-10-16 00:00 China Policy & Regulation Regulatory Approval Source language ZH

Neuracle UDI Listings Cover Two BCI System Models and Two Electrode Kit Models

Summary China’s NMPA UDI database lists Neuracle’s NEO-M and NEO-M Pro hand motor function compensation system models under registration certificate 国械注准20263120537, and K1014-25 and K1014-35 implantable EEG electrode kits under 国械注准20263120536. The descriptions identify the system’s implantable components, EEG transceiver, pneumatic glove and software.
Why it matters Reading the records together distinguishes system and component registrations and avoids counting model-specific UDI entries as four separate product approvals.

BCIwiki (bciwiki.com) — China’s National Medical Products Administration (NMPA) unique device identification database lists four records for Neuracle Medical Technology (Shanghai) Co., Ltd. They cover two models of an implantable brain-computer interface system for hand motor function compensation, NEO-M and NEO-M Pro, and two implantable EEG electrode kit models, K1014-25 and K1014-35. The records list separate registration certificate numbers for the systems and the electrode kits.

The current public versions of all four records were updated on October 16, 2026. Their change notes state that the hand motor function compensation system and the implantable EEG electrode kits have no medical insurance codes and that the medical insurance consumables classification codes were removed. These notes concern database coding and do not establish insurance coverage for specific medical services or other items.

The unique device identifiers (UDIs) for NEO-M and NEO-M Pro are 16978309690264 and 16978309690271, respectively. Both system models are listed under registration certificate 国械注准20263120537.

The K1014-25 and K1014-35 electrode kits have UDIs 06978309690021 and 06978309690038, respectively, and are listed under registration certificate 国械注准20263120536. Their descriptions specify cortical electrodes 1014-25 and 1014-35, respectively, along with 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 registered descriptions, the system comprises a BCI implant, an implantable EEG electrode kit, a disposable surgical tool kit, an EEG signal transceiver, a pneumatic glove device, EEG decoding software, medical testing software and clinical management software. All three software products have release version 1.0. The electrode kit has its own registration certificate and is also listed as a system component.

The four records allow readers to cross-reference models, UDIs and registration certificate numbers. UDI listings provide product identification information and do not themselves validate clinical efficacy. Intended uses, conditions of use and differences between models require the respective registration documents; these records do not establish performance differences between NEO-M and NEO-M Pro.

Compiled by BCIwiki from public sources

Neuracle timeline

2026-10 Neuracle Lists Implanted EEG Electrode Kit in NMPA UDI Database 2026-10 Neuracle Lists K1014-35 Implantable EEG Electrode Kit in UDI Database 2026-10 Neuracle Lists Model 1014-25 Cortical Electrode in NMPA UDI Database 2026-10 Neuracle Lists K1014-15 Implantable EEG Electrode Kit in UDI Database All entries →
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