Twelve Neurosurgical Devices and Software Receive NMPA Approval (October 1–31, 2025)

Name of the Registrant:Lepu Medical Electronic Instrument Co., Ltd.

Registration Certificate Number:China Medical Device Registration No. 20253122148

Structure and Composition/Main Components:Composed of a stimulator (with a quadripolar electrode lead connector) and a torque wrench.

Scope of Application/Intended Use:Used in conjunction with specific implantable deep brain stimulation electrodes and extension leads produced by our company to deliver electrical stimulation to the subthalamic nucleus (STN), serving as an adjunctive treatment for certain symptoms in advanced primary Parkinson's disease patients who are not adequately controlled by medication.

Name of Registrant:Lepu Medical Electronic Instrument Co., Ltd.

Registration Certificate Number:China Medical Device Registration No. 20253122150

Structure and Composition/Main Components:The implantable deep brain stimulation electrode assembly consists of an implantable deep brain stimulation electrode lead, accessories, and an electrode fixation kit (Model: NT201). The accessories include a protective sleeve, guide wire, bone hole seat, washer, bone hole cover, temporary protective sleeve, and test guide wire; the electrode fixation kit includes a base, fixing pad, fixing cover, base handle, placement tool (grey and blue), placement tool (transparent and blue), screwdriver, and skull screws.

Scope of Application/Intended Use:Used in conjunction with the specific implantable deep brain stimulator and extension leads produced by our company to electrically stimulate the subthalamic nucleus (STN) for adjunctive treatment of certain symptoms in advanced primary Parkinson's disease patients who are not effectively controlled by medication.

Name of Registrant:Lepu Medical Electronic Instrument Co., Ltd

Registration Certificate Number:China Medical Device Registration No. 20253122152

Structure and Composition/Main Components:Composed of implantable deep brain neurostimulation extension leads, sleeves, and spare fastening screws.

Scope of Application/Intended Use:Used in conjunction with specific implantable deep brain stimulators and stimulation electrodes produced by our company to deliver electrical stimulation to the subthalamic nucleus (STN), serving as an adjunctive treatment for certain symptoms in advanced primary Parkinson's disease patients who are not effectively controlled by medication.

Name of Registrant:Genlight Neurotech

Registration Certificate Number:China Medical Device Registration No. 20253212083

Structure and Composition/Main Components:Composed of installation USB drive and key. Functional modules include: General Function Module, System Login Module, Patient Management Module, Image Screening Module, Image Registration Module, Surgical Planning Module, Result Export Module.

Scope of Application/Intended Use:Used in medical institutions, in conjunction with the company's magnetic resonance-guided semiconductor laser treatment device (AP101), for the formulation of stereotactic head surgery plans.

Name of Registrant:Beijing Brainlab Technology Co., Ltd.

Registration Certificate Number:China Medical Device Registration No. 20253012151

Structure and Composition/Main Components:Composed of the main console cart (including robotic arm), optical tracking and positioning cart, and accessories.

Scope of Application/Intended Use:Applicable for navigation and positioning of surgical instruments and implants in brain surgery and adult spinal surgery.

Name of Registrant:Genlight Neurotech

Registration Certificate Number:China Medical Device Registration No. 20253012082

Structure and Composition/Main Components:Consists of a medical optical fiber catheter assembly and cooling water pipe.

Scope of Application/Intended Use:This product is used in medical institutions, in conjunction with the magnetic resonance-guided semiconductor laser treatment device (AP101), for performing laser ablation on localized lesions in patients with drug-resistant epilepsy (focal seizures, with a well-defined epileptogenic zone or clear seizure propagation pathway). This includes patients aged 2 years and above with epilepsy caused by hypothalamic hamartoma, patients aged 5 years and above with epilepsy due to focal cortical dysplasia, and patients aged 18 years and above with mesial temporal lobe epilepsy.

Name of Registrant:Genlight Neurotech

Registration Certificate Number:China Medical Device Registration No. 20253012081

Structure and Composition/Main Components:Consisting of a main unit and accessories, including control key, mouse, keyboard, USB key, power cord, foot switch, access control connector, and transmission fiber.

Scope of Application/Intended Use:This product is used in medical institutions, in conjunction with our company's disposable laser fiber kit, for laser treatment of local lesions in patients with drug-resistant epilepsy (focal seizures, with a clear epileptogenic zone or defined epilepsy conduction pathway); including epilepsy patients over the age of 2 caused by hypothalamic hamartoma, epilepsy patients over the age of 5 caused by focal cortical dysplasia, and medial temporal lobe epilepsy patients over the age of 18.

Name of Registrant:Shanghai Qimu Medical Device Co., Ltd.

Registration Certificate Number:China Medical Device Registration No. 20253142059

Structure and Composition/Main Components:Absorbable Hemostatic Fluid Gelatin consists of fluid gelatin, a delivery system, and auxiliary tools. The fluid gelatin is a paste-like solid composed of porcine-derived gelatin, sterile water for injection, and glycerin. The delivery system and auxiliary tools include a flexible green delivery catheter, a trimmable white delivery catheter, 1 liquid transfer cup, 1 syringe (containing fluid gelatin), and 1 empty syringe.

Scope of Application/Intended Use:This product is suitable for auxiliary hemostasis of bone, dura mater, and venous sinuses in neurosurgical procedures when bleeding from capillaries, veins, and small arteries cannot be effectively controlled by compression, ligation, or other traditional methods, or when such methods are not feasible.

Name of Registrant:Nanjing Kotai Colin Medical Technology Co., Ltd.

Registration Certificate Number:China Medical Device Registration No. 20253072153

Structure and Composition/Main Components:The disposable neurostimulation probe consists of a probe, heat shrink tubing, a handle, a protective sleeve, and probe electrode wires.

Scope of Application/Intended Use:This product is used in conjunction with specific equipment for intraoperative identification and localization of the facial nerve, vagus nerve, and recurrent laryngeal nerve.

Name of Registrant:Wuhan United Imaging Intelligence Healthcare Technology Co., Ltd.

Registration Certificate Number:China Medical Device Registration No. 20253012146

Structure and Composition/Main Components:The product consists of a main unit, a transducer, a footswitch, a disposable ultrasonic bone surgery blade, a disposable fluid line, and a torque wrench.

Scope of Application/Intended Use:This product is used in medical institutions to perform cutting, grinding, and drilling of bone tissue during spinal, neurosurgical, and maxillofacial (excluding oral surgery) procedures.

Name of Registrant:Dabo Medical Technology Co., Ltd.

Registration Certificate Number:China Medical Device Registration No. 20253132024

Structure and Composition/Main Components:The product is composed of a cable, lock, and needle. The cable is made of Ti6Al4V ELI material conforming to the ISO 5832-3 standard, while the lock and needle are made of TA2G pure titanium material in accordance with the GB/T 13810 standard. It is provided in non-sterile packaging.

Scope of Application/Intended Use:This product is suitable for internal fixation in cervical spine surgery, used for fixation under the lamina and between spinous processes. The applicable segments are C1-C7. It can be used alone or in conjunction with spinal internal fixation system products made of titanium material from the same system produced by this company.

Name of Registrant:Hunan Huaxiang Medical Technology Co., Ltd.

Registration Certificate Number:China Medical Device Registration No. 20253132040

Structure and Composition/Main Components:The product is made from TC4 titanium alloy powder material conforming to the YY/T 1701 standard through selective laser melting technology. The product consists of a trabecular bone-like porous structure and a solid structure. The product surface has not undergone anodic oxidation treatment. The product is delivered in two packaging states: sterilized and non-sterilized. The sterilized packaging products are sterilized by gamma-ray irradiation, with a sterilization validity period of 5 years.

Scope of Application/Intended Use:Intended for use with spinal fixation systems, suitable for interbody fusion procedures in the cervical spine (C2/3-C7/T1) and thoracolumbar spine (T1/2-L5/S1) (requires bone grafting around the product).