Changzhou RuiShenAn's Implantable Neural Stimulation Electrode Sheet Enters Priority Review Pathway Ahead of IPO Filing
Rishena Medical
Implantable Medical Device R&D and Production Manufacturer
To the PublicInBrain Science Product FieldWith outstanding professional strength and profound project service experience, including implantable sacral nerve stimulators, implantable rechargeable deep brain interfaces, transcranial magnetic stimulators, intracranial deep thermal coagulation electrodes, electroencephalographs, non-invasive EEG electrodes, cerebral blood flow regulation function data processing software, and near-infrared spectroscopy brain function imaging systemsProvide high-quality products such asRegistration Regulations, System Guidance, and Clinical Trial Services, covering the entire process of medical device product listing.
According to the requirements of the "Priority Approval Procedure for Medical Devices," the Priority Approval Medical Device Review Office will publicly display projects that meet the priority approval criteria after review. The public display period is from April 15, 2026, to April 22, 2026.
Serial Number | Acceptance Number | Product Name | Applicant | Reason for Agreement |
1 | CQZ2600628 | Implantable Neurostimulation Patch Electrode | Rishena Medical Co., Ltd. | This product is a medical device listed in the "Priority Approval High-End Medical Device Catalog (2025 Edition)." |
During the public announcement period, if any organization or individual has objections, they may fill out the objection form for the priority approval of medical device projects and submit it to our center's email address: gcdivision@cmde.org.cn.
National Medical Products Administration
Center for Medical Device Evaluation
April 15, 2026
Compiled by: TACRO
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