中 / EN
2026-06-17 00:00 China Policy & Regulation Regulatory Approval Source language EN

Neuracle Registers UDI for NEO-M Hand Motor Function Compensation System

Summary Neuracle registered the NEO-M Implantable Brain-Computer Interface Hand Motor Function Compensation System in the NMPA Medical Device Unique Identification database. Its registration certificate number is 国械注准20263120537. According to the company's description, the system includes a BCI implant, an implantable EEG electrode kit, a disposable surgical tool kit, an EEG signal transceiver, a pneumatic glove device, and EEG decoding, medical testing, and clinical management software. All three software products have release version 1.0. The entry identifies the product and its components; UDI registration itself does not validate clinical efficacy or safety.
Why it matters The description covers implantable components, external equipment, and software rather than an electrode or implant alone. The model, UDI, and registration certificate number identify the product; its name does not establish its scope of use.

BCIwiki (bciwiki.com) — According to information registered by Neuracle in China's National Medical Products Administration (NMPA) Medical Device Unique Identification database, its Implantable Brain-Computer Interface Hand Motor Function Compensation System has the model designation NEO-M. Its unique device identifier (UDI) is 16978309690264, and its registration certificate number is 国械注准20263120537.

The company's product description lists a brain-computer interface (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 entry describes the product's identifiers and system components. UDI registration itself does not validate clinical efficacy or safety, and the phrase "hand motor function compensation" in the product name should not be treated as an established functional outcome. The specific scope of use and operating conditions need to be checked against the corresponding registration documents.

Compiled by BCIwiki from public sources

Sources · 1
udi.nmpa.gov.cn 2026-06-17

Neuracle timeline

2026-10 Neuracle Lists Model 1014-25 Cortical Electrode in NMPA UDI Database 2026-10 Neuracle Lists Implanted EEG Electrode Kit in NMPA UDI Database 2026-10 Neuracle Lists Model 1014-15 Cortical Electrode in NMPA UDI Database 2026-10 Neuracle Lists K1014-35 Implantable EEG Electrode Kit in UDI Database All entries →
Read original ↗
Suggest a correction Revisions · none 中 / EN
© 2026 BCIwiki.com Digest Topics Tips Subscribe Revisions About