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

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

Summary Neuracle Medical Technology (Shanghai) Co., Ltd. registered the Implantable Brain-Computer Interface Hand Motor Function Compensation System in the NMPA Medical Device Unique Identification database. Its model is NEO-M Pro, and its registration certificate number is 国械注准20263120537. The description lists a BCI implant, an implantable EEG electrode kit, a disposable surgical tool kit, an EEG signal transceiver, a pneumatic glove device, and three software products, each with release version 1.0. The entry provides product identification and composition information; UDI registration itself should not be interpreted as validation of clinical efficacy or safety.
Why it matters The entry covers a system comprising implantable components, a signal transceiver, a pneumatic glove, and software. Its name, model, and registration certificate number identify the product, but the name alone does not establish eligible patients or the extent of functional benefit.

BCIwiki (bciwiki.com) — According to information registered by Neuracle Medical Technology (Shanghai) Co., Ltd., China, in the 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 Pro. Its unique device identifier (UDI) is 16978309690271, 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 identifies the system and its components. UDI registration itself does not validate clinical efficacy or safety, and the phrase "hand motor function compensation" in the product name is not an established functional outcome. The specific scope of use and operating conditions should be checked separately against the product's registration documents.

Compiled by BCIwiki from public sources

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

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