Medtronic Receives NMPA Approval for Two Innovative Cardiac Ablation Devices
Medtronic
Medical Device Manufacturer
On September 3, the National Medical Products Administration (NMPA) announced that the "Cardiac Pulsed Field Ablation System" and "Single-Use Cardiac Pulsed Field Ablation Catheter," produced by Medtronic, were approved for marketing, becoming the 295th and 296th innovative medical device products to be approved for sale in China.
Recently, the National Medical Products Administration approved Medtronic's registration applications for two innovative products: the "Cardiac Pulsed Field Ablation System" and the "Single-Use Cardiac Pulsed Field Ablation Catheter."
The cardiac pulsed field ablation system consists of a generator, controller (optional), footswitch (optional), EGM cable, and a single-use catheter interface cable. The single-use cardiac pulsed field ablation catheter is composed of electrodes, a catheter body, and a handle.
The above two products are used in conjunction, utilizing the non-thermal effect principle of pulsed electric fields to treat drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation or drug-refractory, recurrent, symptomatic persistent atrial fibrillation (with episodes lasting less than one year). Compared with traditional radiofrequency ablation and cryoablation products, this product achieves selective destruction of myocardial tissue, avoiding the risk of damage to surrounding tissues caused by temperature transfer.
The drug regulatory department will strengthen the post-market supervision of this product to protect the safety of patients using the device.
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48 | Implantable Sacral Nerve Stimulator Kit | Beijing PINS Medical Co., Ltd. | 2018-9-28 | Beijing | China Medical Device Registration Certificate 20183120410 |
49 | Human SDC2 Gene Methylation Detection Kit (Fluorescence PCR Method) | Guangzhou Kangli Ming Biotechnology Co., Ltd. | 2018-11-16 | Guangdong | China Medical Device Registration No. 20183400506 |
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51 | Medical Electronic Linear Accelerator | Guangdong Zhongneng Accelerator Technology Co., Ltd. | 2018-11-28 | Guangdong | China Medical Device Registration No. 20183050520 |
52 | Valve Annuloplasty Ring | Goldtech Biotechnology (Changshu) Co., Ltd. | 2018-12-07 | Jiangsu | China Medical Device Registration No. 20183130534 |
53 | Neurosurgical Navigation and Positioning System | Huake Precision (Beijing) Medical Technology Co., Ltd. | 2018-12-21 | Beijing | China Medical Device Registration No. 20183010598 |
54 | Medical Linear Accelerator System | Shanghai United Imaging Healthcare Co., Ltd. | 2018-12-24 | Shanghai | China Medical Device Registration Certificate 20183050599 |
55 | Porous Tantalum Bone Filling Material | Chongqing Runze Pharmaceutical Co., Ltd. | 2019-1-7 | Chongqing | China Medical Device Registration No. 20193130001 |
56 | Bioabsorbable Coronary Sirolimus-Eluting Stent System | Lepu (Beijing) Medical Device Co., Ltd. | 2019-2-22 | Beijing | China Medical Device Registration Certificate 20193130093 |
57 | Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-3-12 | Guangdong | China Medical Device Registration No. 20193070154 |
58 | Abdominal Aortic Stent Graft and Delivery System | MicroPort CardioFlow MedTech (Shanghai) Co., Ltd. | 2019-3-19 | Shanghai | China Medical Device Registration No. 20193130182 |
59 | Left Atrial Appendage Closure System | Beijing Medpeak Medical Technology Co., Ltd. | 2019-4-30 | Beijing | CN Medical Device Registration No. 20193130278 |
60 | Left Atrial Appendage Occluder System | Shanghai Pushi Medical Device Technology Co., Ltd. | 2019-5-5 | Shanghai | China Medical Device Registration No. 20193130279 |
61 | Intensity-Modulated Radiation Therapy Planning System Software | Zhongke Chaojing (Anhui) Technology Co., Ltd. | 2019-5-6 | Anhui | China Medical Device Registration Certificate No. 20193210281 |
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67 | Non-invasive Blood Glucose Meter | B&B Medical Technology (Beijing) Co., Ltd. | 2019-8-26 | Beijing | CN Medical Device Registration No. 20193070602 |
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95 | KRAS Gene Mutation and BMP3/NDRG4 Gene Methylation and Fecal Occult Blood Combined Detection Kit (PCR Fluorescent Probe Method - Colloidal Gold Method) | Hangzhou Nuohui Health Technology Co., Ltd. | 2020-11-09 | Zhejiang | China Medical Device Registration No. 20203400845 |
96 | Drug-Eluting PTA Balloon Dilation Catheter | Zhejiang Guichuang Medical Device Co., Ltd. | 2020-11-9 | Zhejiang | CN Medical Device Registration No. 20203030857 |
97 | Peripheral Nerve Repair Grafts | Jiangsu Yitong Bio-Technology Co., Ltd. | 2020-11-17 | Jiangsu | CN Medical Device Registration No. 20203130898 |
98 | CT Imaging Pulmonary Nodule Auxiliary Detection Software | Hangzhou DeepRui BoLian Technology Co., Ltd. | 2020-11-30 | Zhejiang | China Medical Device Registration No. 20203210920 |
99 | Vertebral Artery Rapamycin-Eluting Stent System | Minimally Invasive Shentong Medical Technology (Shanghai) Co., Ltd. | 2020-12-17 | Shanghai | China Medical Device Registration Certificate No. 20203130971 |
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101 | Anchoring Balloon Dilation Catheter | Hunan Aipute Medical Device Co., Ltd. | 2021-1-13 | Hunan | China Medical Device Registration No. 20213030023 |
102 | Single-Use Intravascular Imaging Catheter | Suzhou Argus Medical Technology Co., Ltd. | 2021-3-9 | Jiangsu | CN Medical Device Registration No. 20213060169 |
103 | Disposable Electronic Ureteroscopic Nephroscope | Beijing Beifang Tengda Technology Development Co., Ltd. | 2021-3-16 | Beijing | China Medical Device Registration No. 20213060175 |
104 | Helicobacter pylori 23S rRNA Gene Mutation Detection Kit (PCR-Fluorescence Probe Method) | Shanghai Xinchao Biotechnology Co., Ltd. | 2021-4-1 | Shanghai | China Medical Device Registration No. 20213400227 |
105 | Coronary CT Blood Flow Reserve Fraction Calculation Software | Shenzhen Ruixin Intelligent Medical Technology Co., Ltd. | 2021-4-14 | Guangdong | China Medical Device Registration No. 20213210270 |
106 | Transcatheter Aortic Valve System | Peijia Medical Technology (Suzhou) Co., Ltd. | 2021-4-19 | Jiangsu | China Medical Device Registration No. 20213130275 |
107 | Temporary Pacemaker | Shenzhen Xianjian Xinkang Medical Electronics Co., Ltd. | 2021-4-26 | Guangdong | China Medical Device Registration Certificate No. 20213120299 |
108 | Paclitaxel-Eluting PTCA Balloon Dilatation Catheter | Zhejiang Batai Medical Technology Co., Ltd. | 2021-4-30 | Zhejiang | China Medical Device Registration No. 20213030297 |
109 | Peripheral Nerve Conduit | Beijing Huifukang Medical Technology Co., Ltd. | 2021-4-30 | Beijing | China Medical Device Registration No. 20213130298 |
110 | 3D Electronic Laparoscopic Endoscope | Minimally Invasive (Shanghai) Medical Robotics Co., Ltd. | 2021-6-4 | Shanghai | China Medical Device Registration No. 20213060384 |
111 | Transcatheter Aortic Valve System | Peijia Medical Technology (Suzhou) Co., Ltd. | 2021-6-24 | Jiangsu | CN Medical Device Registration No. 20213130464 |
112 | Self-expanding Intracranial Aneurysm Coiling System | Sequent Medical Inc. | 2021-6-30 | United States | China Medical Device Registration No. 20213130233 |
113 | Steep Pulse Therapy Device | Tianjin Yingtai Li'an Kang Medical Technology Co., Ltd. | 2021-7-5 | Tianjin | China Medical Device Registration No. 20213090497 |
114 | Coronary CT Blood Flow Reserve Fraction Calculation Software | Beijing Xinshiji Medical Technology Co., Ltd. | 2021-7-29 | Beijing | CN Medical Device Registration No. 20213210574 |
115 | Intracranial Drug-Eluting Stent System | Sino Medical Science and Technology Co., Ltd. | 2021-7-29 | Tianjin | China Medical Device Registration No. 20213130575 |
116 | Caval Filter | Kossel Medical Technology (Suzhou) Co., Ltd. | 2021-8-5 | Jiangsu | CN Medical Device Registration No. 20213130594 |
117 | Unicompartmental Knee Prosthesis | Beijing Chunli Zhengda Medical Devices Co., Ltd. | 2021-8-6 | Beijing | China Medical Device Registration Certificate 20213130600 |
118 | Ultrasound Diagnostic Equipment for Endoscopes | Shenzhen Imagic Medical Technology Co., Ltd. | 2021-8-16 | Guangdong | China Medical Device Registration Certificate 20213060608 |
119 | Mechanical Detachment Coil | Shanghai Wallaby Medical Technology Co., Ltd. | 2021-8-18 | Shanghai | CN Medical Device Registration No. 20213130649 |
120 | Transcatheter Aortic Valve and Retrievable Delivery System | Shanghai MicroPort CardioFlow Medtech Co., Ltd. | 2021-8-30 | Shanghai | China Medical Device Registration No. 20213130655 |
121 | Oral Implant Surgery Navigation and Positioning Equipment | Yake Wisdom (Beijing) Technology Co., Ltd. | 2021-9-13 | Beijing | CN Medical Device Registration No. 20213010713 |
122 | Disposable Hydrodynamic Debridement Blade | Huizhou Haizhuokexing Medical Co., Ltd. | 2021-9-27 | Guangdong | CN Medical Device Registration No. 20213010779 |
123 | Hydrodynamic Therapy Device | Huizhou Haizhuokexing Medical Co., Ltd. | 2021-9-27 | Guangdong | CN Medical Device Registration No. 20213010780 |
124 | Medical Electron Linear Accelerator | Suzhou Leitai Medical Technology Co., Ltd. | 2021-10-9 | Jiangsu | CN Medical Device Registration No. 20213050789 |
125 | Balloon-expandable Vascular Stent Graft System | W-L- Gore & Associates, Inc. | 2021-10-19 | United States | CN Medical Device Registration Import 20213130411 |
126 | Intraperitoneal Endoscopic Surgical Equipment | Shandong Weigao Surgical Robot Co., Ltd. | 2021-10-26 | Shandong | CN Medical Device Registration No. 20213010848 |
127 | Pre-implantation Chromosome Aneuploidy Detection Kit (Reversible Terminator Sequencing Method) | Beijing Zhongyi Kangwei Medical Device Co., Ltd. | 2021-11-2 | Beijing | CN Medical Device Registration No. 20213400868 |
128 | Continuous Glucose Monitoring System | Shenzhen Silicon Sensing Technology Co., Ltd. | 2021-11-3 | Guangdong | China Medical Device Registration No. 20213070871 |
129 | Continuous Glucose Monitoring System | MicroTech Medical (Hangzhou) Co., Ltd. | 2021-11-3 | Zhejiang | China Medical Device Registration No. 20213070872 |
130 | Biological Hernia Repair Patch | Zhuo Ruan Medical Technology (Suzhou) Co., Ltd. | 2021-11-8 | Jiangsu | China Medical Device Registration No. 20213130873 |
131 | Implantable Left Ventricular Assist System | Suzhou T同心 Medical Device Co., Ltd. | 2021-11-24 | Jiangsu | China Medical Device Registration Certificate 20213120987 |
132 | Artificial Cornea | Beijing Miherr Medical Device Co., Ltd. | 2021-12-3 | Beijing | China Medical Device Registration No. 20213161017 |
133 | Branched Intraoperative Stent System | Shanghai MicroPort CardioFlow Medtech Corporation | 2021-12-14 | Shanghai | China Medical Device Registration No. 20213131059 |
134 | Transcatheter Aortic Valve System | MEDTRONIC Inc. | 2021-12-24 | United States | CN Medical Device Registration Import 20213130538 |
135 | Implantable Rechargeable Spinal Cord Neurostimulator | Beijing PINS Medical Co., Ltd. | 2022-1-10 | Beijing | CN Medical Device Registration No. 20223120019 |
136 | Implantable Spinal Cord Neurostimulator | Beijing PINS Medical Co., Ltd. | 2022-1-10 | Beijing | China Medical Device Registration No. 20223120020 |
137 | Implantable Spinal Cord Neurostimulation Electrode | Beijing PINS Medical Co., Ltd. | 2022-1-10 | Beijing | CN Medical Device Registration No. 20223120021 |
138 | Implantable Spinal Cord Neurostimulation Extension Lead | Beijing PINS Medical Co., Ltd. | 2022-1-10 | Beijing | China Medical Device Registration No. 20223120022 |
139 | Implantable Spinal Cord Neurostimulation Electrode | Beijing PINS Medical Co., Ltd. | 2022-1-10 | Beijing | China Medical Device Registration No. 20223120023 |
140 | Neurosurgical Navigation and Positioning System | Huake Precision (Beijing) Medical Technology Co., Ltd. | 2022-1-10 | Beijing | CN Medical Device Registration No. 20223010024 |
141 | Straight-tube Thoracic Aortic Stent Graft System | Shanghai MicroPort CardioFlow Medtech Corporation | 2022-1-06 | Shanghai | China Medical Device Registration No. 20223130009 |
142 | Implantable Deep Brain Stimulation Extension Lead Kit | Beijing PINS Medical Co., Ltd. | 2022-1-20 | Beijing | China Medical Device Registration No. 20223120084 |
143 | Dual-channel Rechargeable Implantable Deep Brain Stimulation Pulse Generator Kit | Beijing PINS Medical Co., Ltd. | 2022-1-20 | Beijing | China Medical Device Registration No. 20223120085 |
144 | Implantable Deep Brain Stimulation Electrode Lead Kit | Beijing PINS Medical Co., Ltd. | 2022-1-20 | Beijing | CN Medical Device Registration No. 20223120086 |
145 | Dual-channel Implantable Deep Brain Stimulation Pulse Generator Kit | Beijing PINS Medical Co., Ltd. | 2022-1-20 | Beijing | China Medical Device Registration No. 20223120087 |
146 | Intraperitoneal Endoscopic Surgical System | Shanghai MicroPort Medical Robot (Group) Co., Ltd. | 2022-1-25 | Shanghai | China Medical Device Registration No. 20223010108 |
147 | Gastrointestinal Vibrating Capsule System | Shanghai Anpu Medical Technology Co., Ltd. | 2022-2-25 | Shanghai | China Medical Device Registration No. 20223090282 |
148 | Mobile Head and Neck Magnetic Resonance Imaging System | Foshan Ruijiatu Medical Technology Co., Ltd. | 2022-3-2 | Guangdong | China Medical Device Registration No. 20223060289 |
149 | Intracranial Hemorrhage CT Image Triage Assistance Software | Shanghai United Imaging Intelligence Healthcare Technology Co., Ltd. | 2022-3-9 | Shanghai | CN Medical Device Registration No. 20223210309 |
150 | Magnetic Resonance Imaging System | Xingaoyi Medical Equipment Co., Ltd. | 2022-4-2 | Zhejiang | China Medical Device Registration No. 20223060431 |
151 | Hip Joint Replacement Surgery Navigation and Positioning System | Hangzhou Jianjia Robotics Co., Ltd. | 2022-4-6 | Zhejiang | China Medical Device Registration No. 20223010462 |
152 | Knee Joint Replacement Surgery Navigation and Positioning System | Suzhou MicroPort MedBot Co., Ltd. | 2022-4-20 | Jiangsu | CN Medical Device Registration No. 20223010509 |
153 | Spinal Cord Stimulation Test Electrode | Beijing PINS Medical Co., Ltd. | 2022-4-20 | Beijing | China Medical Device Registration No. 20223120511 |
154 | Knee Joint Replacement Surgery Navigation and Positioning System | OrthoSaint Robot (Shenzhen) Co., Ltd. | 2022-4-20 | Guangdong | CN Medical Device Registration No. 20223010510 |
155 | Iliac Vein Stent System | Suzhou Tianhong Shengjie Medical Device Co., Ltd. | 2022-4-20 | Jiangsu | CN Medical Device Registration No. 20223130512 |
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157 | Intravascular Imaging Device | Panorama Hengsheng (Beijing) Science and Technology Co., Ltd. | 2022-5-18 | Beijing | China Medical Device Registration No. 20223060642 |
158 | Single-Use Intravascular Imaging Catheter | Panorama Hengsheng (Beijing) Science and Technology Co., Ltd. | 2022-5-18 | Beijing | China Medical Device Registration No. 20223060641 |
159 | Patient Programmer Charger | Beijing PINS Medical Co., Ltd. | 2022-5-20 | Beijing | China Medical Device Registration No. 20223120676 |
160 | Thoracic Aortic Stent System | Hangzhou Weiqiang Medical Technology Co., Ltd. | 2022-5-23 | Zhejiang | China Medical Device Registration No. 20223130685 |
161 | Ultrasonic Diagnostic Equipment for Gastrointestinal Endoscopy | Beijing Huachuang Kexin Health Technology Co., Ltd. | 2022-6-2 | Beijing | China Medical Device Registration No. 20223060721 |
162 | Single-Use Cryoablation Balloon Catheter | Ningbo Shengjie Kang Biotechnology Co., Ltd. | 2022-6-24 | Zhejiang | China Medical Device Registration No. 20223010763 |
163 | Intraperitoneal Endoscopic Surgical System | Suzhou Kangduo Robotics Co., Ltd. | 2022-6-24 | Jiangsu | CN Medical Device Registration No. 20223010762 |
164 | Transcatheter Pulmonary Valve System | Hangzhou Qiming Medical Device Co., Ltd. | 2022-7-11 | Zhejiang | China Medical Device Registration No. 20223130862 |
165 | Implantable Left Ventricular Assist System | Aerospace Taixin Technology Co., Ltd. | 2022-7-13 | Tianjin | China Medical Device Registration No. 20223120892 |
166 | Gamma Beam Stereotactic Radiosurgery System | Xi'an Dali Group Co., Ltd. | 2022-7-13 | Shaanxi | CN Medical Device Registration No. 20223050891 |
167 | Dual-source Cone Beam Computed Tomography Equipment for Otorhinolaryngology | Beijing Langshi Instrument Co., Ltd. | 2022-7-19 | Beijing | CN Medical Device Registration No. 20223060951 |
168 | Single-Use Intravascular Ultrasound Diagnostic Catheter | Shenzhen Northcore Life Technology Co., Ltd. | 2022-7-25 | Guangdong | CN Medical Device Registration No. 20223060974 |
169 | Intravascular Ultrasound Diagnostic Equipment | Shenzhen Northcore Life Technology Co., Ltd. | 2022-7-25 | Guangdong | China Medical Device Registration No. 20223060975 |
170 | Electronic Colonoscopy Image-Assisted Detection Software for Intestinal Polyps | Chengdu Micro Recognition Medical Device Co., Ltd. | 2022-8-2 | Sichuan | CN Medical Device Registration No. 20223210981 |
171 | Absorbable Regenerated Oxidized Cellulose Hemostatic Particles | Ethicon,LLC | 2022-8-3 | United States | China Medical Device Registration No. 20223140374 |
172 | Encephalitis/Meningitis Multiplex Pathogen Nucleic Acid Combined Detection Kit (Closed Nested Multiplex PCR Melting Curve Method) | BioFire Diagnostics，LLC | 2022-8-5 | United States | China Medical Device Registration No. 20223400387 |
173 | Anastomotic Reinforcement Patch | Beijing Bohui Ruijin Biotechnology Co., Ltd. | 2022-8-3 | Beijing | China Medical Device Registration No. 20223130983 |
174 | Medical Adhesive | Hangzhou Yahui Biotechnology Co., Ltd. | 2022-8-29 | Zhejiang | China Medical Device Registration No. 20223021122 |
175 | Auxiliary Diagnostic Software for Fundus Images of Chronic Glaucoma-like Optic Neuropathy | Tencent Medical Health (Shenzhen) Co., Ltd. | 2022-8-31 | Guangdong | China Medical Device Registration Certificate 20223211140 |
176 | Magnetic Resonance Imaging System | Shanghai United Imaging Healthcare Co., Ltd. | 2022-8-31 | Shanghai | China Medical Device Registration No. 20223061141 |
177 | Umiromab Coated Coronary Balloon Dilation Catheter | Shandong Jiwei Medical Products Co., Ltd. | 2022-9-19 | Shandong | CN Medical Device Registration No. 20223031247 |
178 | Proton Therapy System | Shanghai Aipuqiang Particle Equipment Co., Ltd. | 2022-9-26 | Shanghai | China Medical Device Registration No. 20223051290 |
179 | Integrated Membrane Oxygenator | Dongguan Kewei Medical Device Co., Ltd. | 2022-9-27 | Guangdong | China Medical Device Registration No. 20223101297 |
180 | Intracranial Aneurysm Surgery Planning Software | Qianglian Zhichuang (Beijing) Technology Co., Ltd. | 2022-10-11 | Beijing | China Medical Device Registration No. 20223211346 |
181 | Flow Diverter Stent | Aikang Medical Devices (Beijing) Co., Ltd. | 2022-10-24 | Beijing | China Medical Device Registration No. 20223131392 |
182 | Aspheric Diffractive Multifocal Intraocular Lens | Aibonuode (Beijing) Medical Technology Co., Ltd. | 2022-10-28 | Beijing | China Medical Device Registration No. 20223161440 |
183 | Left Atrial Appendage Occluder System | Hangzhou Denovo Electrophysiology Medical Technology Co., Ltd. | 2022-11-09 | Zhejiang | China Medical Device Registration No. 20223131498 |
184 | Artificial Blood Vessel | Jiangsu Baiyouda Life Technology Co., Ltd. | 2022-11-17 | Jiangsu | China Medical Device Registration No. 20223131515 |
185 | Single-Use Pressure Monitoring Magnetic Localization RF Ablation Catheter | Shanghai MicroPort EP MedTech Co., Ltd. | 2022-12-01 | Shanghai | China Medical Device Registration No. 20223011571 |
186 | Intraperitoneal Endoscopic Surgical System | Shenzhen Jingfeng Medical Technology Co., Ltd. | 2022-12-14 | Guangdong | CN Medical Device Registration No. 20223011623 |
187 | Intravascular Ultrasound Diagnostic Equipment | Shenzhen Sonoscape Biomedical Technology Co., Ltd. | 2022-12-14 | Guangdong | CN Medical Device Registration No. 20223061658 |
188 | Single-Use Intravascular Ultrasound Diagnostic Catheter | Shanghai Aisheng Biomedical Technology Co., Ltd. | 2022-12-14 | Shanghai | China Medical Device Registration No. 20223061659 |
189 | Medical Angiography X-ray Machine | Shanghai United Imaging Healthcare Co., Ltd. | 2022-12-30 | Shanghai | China Medical Device Registration No. 20223061821 |
190 | Patient Monitor | Shenzhen Comen Medical Devices Co., Ltd. | 2023-1-5 | Guangdong | CN Med Approval 20233070003 |
191 | Hybrid Closed-Loop Insulin Delivery System | Medtronic MiniMed | 2023-2-27 | United States | CN Medical Device Registration No. 20233140061 |
192 | Hemodialysis Urea Clearance Calculation Software | Beijing Infomagic Information Technology Co., Ltd. | 2023-2-27 | Beijing | China Medical Device Registration No. 20233210219 |
193 | Collagen Cartilage Repair Scaffold | Ubiosis Co., Ltd | 2023-4-4 | Korea | CN Medical Device Registration Import 20233130129 |
194 | Magnetic Resonance-Guided Semiconductor Laser Therapy Device | Huake Precision (Beijing) Medical Technology Co., Ltd. | 2023-4-4 | Beijing | CN Medical Device Registration No. 20233010449 |
195 | Coronary CT Blood Flow Reserve Fraction Calculation Software | Shanghai BoDong Medical Technology Co., Ltd. | 2023-4-4 | Shanghai | China Medical Device Registration No. 20233210450 |
196 | Disposable Laser Fiber Kit | Huake Precision (Beijing) Medical Technology Co., Ltd. | 2023-4-13 | Beijing | China Medical Device Registration Certificate No. 20233010485 |
197 | Intraocular Lens | Alcon Laboratories, Incorporated | 2023-4-17 | United States | CN Medical Device Registration Import 20233160146 |
198 | Coronary Artery Function Measurement System | Suzhou Runmed Medical Technology Co., Ltd. | 2023-4-20 | Jiangsu | China Medical Device Registration Certificate 20233070520 |
199 | Metal Additive Manufacturing Thoracolumbar Fusion Matched Prosthesis System | Beijing Aikang Yicheng Medical Equipment Co., Ltd. | 2023-4-21 | Beijing | CN Medical Device Registration No. 20233130524 |
200 | Self-expanding Particle-loaded Biliary Stent | Nanjing Rongsheng Medical Technology Co., Ltd. | 2023-5-11 | Jiangsu | CN Medical Device Registration Approval 20233130621 |
201 | Electronic Colon Polyp Detection Software for Lower Gastrointestinal Endoscopic Images | Wuhan Chujingling Medical Technology Co., Ltd. | 2023-5-12 | Hubei | China Medical Device Registration Certificate 20233210629 |
202 | Intravascular Imaging Device | Conavi Medical Inc. | 2023-5-16 | Canada | CN Medical Device Registration Import 20233060200 |
203 | Radiotherapy Planning Software | Shanghai United Imaging Healthcare Co., Ltd. | 2023-5-23 | Shanghai | China Medical Device Registration No. 20233210665 |
204 | Electronic Colon Polyp Endoscopic Image-Assisted Detection Software | Tencent Medical Health (Shenzhen) Co., Ltd. | 2023-6-1 | Guangdong | China Medical Device Registration No. 20233210707 |
205 | Accessories for Single-Use Coronary Intervention Surgical Control System | Corindus Inc. | 2023-6-1 | United States | China Medical Device Registration No. 20233010226 |
206 | Coronary Interventional Surgery Control System | Corindus Inc. | 2023-6-1 | United States | CN Medical Device Registration Import 20233010225 |
207 | Carbon Ion Therapy System | Lanzhou Kejin Taiji New Technology Co., Ltd. | 2023-6-2 | Gansu | CN Medical Device Registration No. 20233050708 |
208 | Implantable Left Ventricular Assist System | Shenzhen Core Medical Technology Co., Ltd. | 2023-6-5 | Guangdong | CN Medical Device Registration No. 20233120716 |
209 | Multimodal Tumor Treatment System | Shanghai Meijie Medical Technology Co., Ltd. | 2023-6-8 | Shanghai | CN Medical Device Registration No. 20233010773 |
210 | Implantable Sacral Nerve Stimulator | Hangzhou Chengnuo Medical Technology Co., Ltd. | 2023-6-14 | Zhejiang | China Medical Device Registration No. 20233120807 |
211 | Implantable Sacral Nerve Stimulation Extension Lead | Hangzhou Chengnuo Medical Technology Co., Ltd. | 2023-6-14 | Zhejiang | CN Medical Device Registration No. 20233120808 |
212 | Implantable Sacral Nerve Stimulation Electrode | Hangzhou Chengnuo Medical Technology Co., Ltd. | 2023-6-14 | Zhejiang | CN Medical Device Registration No. 20233120809 |
213 | Puncture Surgery Navigation and Positioning System | True Health (Beijing) Medical Technology Co., Ltd. | 2023-6-15 | Beijing | CN Medical Device Registration No. 20233010810 |
214 | Zirconium Niobium Alloy Femoral Head | Suzhou Minimally Invasive Joint Medical Technology Co., Ltd. | 2023-6-15 | Jiangsu | China Medical Device Registration No. 20233130813 |
215 | Shock Wave Therapy Device | Shenzhen Huikang Precision Instrument Co., Ltd. | 2023-6-20 | Guangdong | CN Medical Device Registration No. 20233090834 |
216 | Single-Port Laparoscopic Surgery System | Beijing Surui Robotics Co., Ltd. | 2023-6-20 | Beijing | China Medical Device Registration Certificate No. 20233010833 |
217 | Head and Neck X-ray Stereotactic Radiosurgery Treatment System | Raypu Surgical Systems Co., Ltd. | 2023-6-20 | United States | CN Medical Device Registration Import 20233050263 |
218 | Knee Joint Replacement Surgery Navigation and Positioning System | Beijing Tianzhihang Medical Technology Co., Ltd. | 2023-7-13 | Beijing | CN Medical Device Registration No. 20233010962 |
219 | Intraocular Lens | Alcon Laboratories, Incorporated | 2023-7-20 | United States | China Medical Device Registration No. 20233160317 |
220 | Venous Stent System | Suzhou Inlaid Medical Device Co., Ltd. | 2023-7-28 | Jiangsu | CN Medical Device Registration No. 20233131034 |
221 | Medical Electron Linear Accelerator | Xi'an Dali Group Co., Ltd. | 2023-8-1 | Shaanxi | China Medical Device Registration No. 20233051067 |
222 | Single-Use Intravascular Imaging Catheter | Conavi Medical Inc. | 2023-8-1 | Canada | China Medical Device Registration No. 20233060333 |
223 | Rigid Scleral Contact Lens | Shanghai Aikangte Medical Technology Co., Ltd. | 2023-8-3 | Shanghai | China Medical Device Registration No. 20233161081 |
224 | Hip Joint Replacement Surgery Navigation and Positioning System | Hangzhou Lancet Robotics Co., Ltd. | 2023-8-10 | Zhejiang | CN Medical Device Registration No. 20233011155 |
225 | Magnetic Resonance Imaging System | Wuhan Zhongke Polarization Medical Technology Co., Ltd. | 2023-8-16 | Hubei | China Medical Device Registration No. 20233061160 |
226 | Intracranial Thrombectomy Stent | Rapid Medical Ltd. | 2023-8-17 | Israel | CN Medical Device Registration Import 20233030369 |
227 | Balloon Cryoablation Catheter | Shanghai MicroPort EP MedTech Co., Ltd. | 2023-8-23 | Shanghai | National Medical Device Registration Approval 20233011225 |
228 | Cryogenic Ablation Device | Shanghai MicroPort EP MedTech Co., Ltd. | 2023-8-23 | Shanghai | National Medical Device Registration Approval 20233011226 |
229 | Injectable Recombinant Type III Humanized Collagen Protein Solution | Shanxi Jinbo Biomedical Technology Co., Ltd. | 2023-8-25 | Shanxi | China Medical Device Registration Certificate 20233131245 |
230 | Mitral Valve Clip System | Shanghai Hanyu Medical Technology Co., Ltd. | 2023-9-7 | Shanghai | CN Medical Device Registration No. 20233131292 |
231 | TMB Detection Kit for Non-Small Cell Lung Cancer Tissue (Reversible Terminator Sequencing) | Nanjing Shihew Medical Device Co., Ltd. | 2023-10-12 | Jiangsu | CN Medical Device Registration No. 20233401452 |
232 | X-ray Computed Tomography Equipment | Siemens Healthineers Limited Siemens Healthcare GmbH | 2023-10-16 | Germany | China Medical Device Registration No. 20233060455 |
233 | Joint Replacement Surgery Simulation Software | Beijing Changmu Valley Medical Technology Co., Ltd. | 2023-10-23 | Beijing | CN Medical Device Registration No. 20233211543 |
234 | Proton Therapy System | Varian Medical Systems Particle Therapy Co., Ltd. | 2023-11-1 | Germany | China Medical Device Registration No. 20233050480 |
235 | Single Photon Emission and X-ray Computed Tomography System | Beijing Yongxin Medical Equipment Co., Ltd. | 2023-11-7 | Beijing | China Medical Device Registration No. 20233061628 |
236 | Additively Manufactured Polyether Ether Ketone (PEEK) Cranial Defect Repair Implant | Xi'an Contec Medical Technology Co., Ltd. | 2023-11-9 | Shaanxi | China Medical Device Registration No. 20233131652 |
237 | Additively Manufactured Customized Artificial Knee Joint Prosthesis | Naton Biotechnology (Beijing) Co., Ltd. | 2023-11-17 | Beijing | CN Medical Device Registration No. 20233131698 |
238 | Single-port laparoscopic surgery system | Shenzhen Jingfeng Medical Technology Co., Ltd. | 2023-11-24 | Guangdong | CN Medical Device Registration No. 20233011753 |
239 | Single-Use Intracardiac Ultrasound Diagnostic Catheter | Jiangsu Tingsheng Technology Co., Ltd. | 2023-11-28 | Jiangsu | CN Medical Device Registration No. 20233061761 |
240 | Gelatin-Polycaprolactone Layered Gingival Repair Membrane | Nuo Yi Mai Er (Suzhou) Medical Technology Co., Ltd. | 2023-11-29 | Jiangsu | China Medical Device Registration No. 20233171776 |
241 | Transcatheter Mitral Valve Clip System | Hangzhou Dejin Medical Technology Co., Ltd. | 2023-11-29 | Zhejiang | CN Medical Device Registration No. 20233131775 |
242 | Cryogenic Ablation Device | Kangfeng Biotechnology (Shanghai) Co., Ltd. | 2023-12-4 | Shanghai | China Medical Device Registration No. 20233011815 |
243 | Balloon Cryoablation Catheter | Kangfeng Biotechnology (Shanghai) Co., Ltd. | 2023-12-4 | Shanghai | China Medical Device Registration No. 20233011816 |
244 | Pelvic Fracture Reduction Surgical Navigation and Positioning System | Beijing Rosenbott Technology Co., Ltd. | 2023-12-8 | Beijing | CN Medical Device Registration No. 20233011923 |
245 | Biodegradable Magnesium Metal Clip | Suzhou Aoruiji Medical Technology Co., Ltd. | 2023-12-13 | Jiangsu | CN Medical Device Registration No. 20233021931 |
246 | Human Breast Cancer Molecular Subtyping Detection Kit (PCR-Fluorescence Probe Method) | BioNTech Diagnostics LLC | 2023-12-21 | Germany | China Medical Device Registration No. 20233400600 |
247 | Disposable Circular Pulmonary Artery Radiofrequency Ablation Catheter | Wuxi Pulnovo Medical Technology Co., Ltd. | 2023-12-22 | Jiangsu | China Medical Device Registration Certificate 20233012011 |
248 | Single-Use Cardiac Pulsed Field Ablation Catheter | Sichuan Jinjiang Electronic Medical Device Technology Co., Ltd. Company | 2023-12-26 | Sichuan | CN Medical Device Registration No. 20233012053 |
249 | Cardiac Pulsed Field Ablation System | Sichuan Jinjiang Electronic Medical Device Technology Co., Ltd. | 2023-12-26 | Sichuan | CN Medical Device Registration No. 20233012051 |
250 | Proton Therapy System | Varian Medical Systems Particle Therapy Co., Ltd. | 2023-12-26 | Germany | CN Medical Device Registration Import 20233050613 |
251 | Gastric Bypass Stent System | Hangzhou Tangji Medical Technology Co., Ltd. | 2024-1-17 | Zhejiang | China Medical Device Registration Certificate 20243130104 |
252 | IFI44L Gene Methylation Detection Kit (PCR-Melting Curve Method) | Shenzhen Sair Biological Technology Co., Ltd. | 2024-2-5 | Guangdong | China Medical Device Registration No. 20243400284 |
253 | CT Angiography Image-Assisted Detection Software for Intracranial Aneurysms | Hangzhou DeepRui BoLian Technology Co., Ltd. | 2024-2-29 | Zhejiang | CN Medical Device Registration No. 20243210396 |
254 | Passive Instruments and Accessories for Bronchoscopy Operation Control System | Intuitive Medical Company | 2024-3-8 | United States | CN Medical Device Registration Import 20242080127 |
255 | Single-Use Cardiac Pulsed Field Ablation Catheter | Hangzhou Denovo Electrophysiology Medical Technology Co., Ltd. | 2024-3-8 | Zhejiang | China Medical Device Registration No. 20243010461 |
256 | Bronchial Navigation Optical Fiber Localization Catheter Guide | IntuitiveSurgical, Inc. | 2024-3-20 | United States | CN Medical Device Registration No. 20242010154 |
257 | Bronchial Navigation Optical Fiber Localization Catheter | IntuitiveSurgical, Inc. | 2024-3-20 | United States | CN Medical Device Registration Import 20243010156 |
258 | Bronchoscopic Navigation Visualization Probe | IntuitiveSurgical, Inc. | 2024-3-20 | United States | China Medical Device Registration No. 20242060153 |
259 | Bronchoscopic Navigation Operation Control System | IntuitiveSurgical, Inc. | 2024-3-20 | United States | CN Medical Device Registration Import 20243010155 |
260 | Combined Blood Glucose Meter | Jiangsu Jingce Medical Technology Co., Ltd. | 2024-4-11 | Jiangsu | CN Medical Device Registration No. 20243070662 |
261 | Oligosaccharide Chain Detection Kit (Fluorescent Capillary Electrophoresis Method) | Jiangsu XianSiDa Biotechnology Co., Ltd. | 2024-4-11 | Jiangsu | CN Medical Device Registration No. 20243400663 |
262 | Ventricular Assist Device (VAD) | Heart Power Medical (Suzhou) Co., Ltd. | 2024-4-26 | Jiangsu | CN Medical Device Registration No. 20243100773 |
263 | Extracorporeal Ventricular Assist Pump Head and Tubing | XinQing Medical (Suzhou) Co., Ltd. | 2024-4-26 | Jiangsu | CN Medical Device Registration No. 20243100774 |
264 | Disposable Multi-Polar Renal Artery Radiofrequency Ablation Catheter | Medtronic, Inc. | 2024-4-30 | United States | China Medical Device Registration No. 20243010242 |
265 | Renal Artery Radiofrequency Ablation Device | Medtronic, Inc. | 2024-4-30 | United States | China Medical Device Registration Import 20243010243 |
266 | Dual-Channel Rechargeable Implantable Deep Brain Stimulation Pulse Generator Kit | Beijing PINS Medical Co., Ltd. | 2024-5-23 | Beijing | CN Medical Device Registration Approval 20243120979 |
267 | Dual-channel Implantable Deep Brain Stimulation Pulse Generator Kit | Beijing PINS Medical Co., Ltd. | 2024-5-23 | Beijing | CN Medical Device Registration No. 20243120980 |
268 | Implantable Deep Brain Stimulation Electrode Lead Kit | Beijing PINS Medical Co., Ltd. | 2024-5-23 | Beijing | China Medical Device Registration No. 20243120981 |
269 | Implantable Deep Brain Stimulation Extension Lead Kit | Beijing PINS Medical Co., Ltd. | 2024-5-23 | Beijing | China Medical Device Registration Certificate No. 20243120982 |
270 | Pulmonary Artery Thrombectomy Stent System | Shanghai Tengfu Medical Technology Co., Ltd. | 2024-5-31 | Shanghai | CN Medical Device Registration Approval 20243031010 |
271 | Transjugular Intrahepatic Puncture Instrument | Beijing Ailin Medical Technology Co., Ltd. | 2024-5-31 | Beijing | CN Medical Device Registration No. 20243031052 |
272 | Disposable Radiofrequency Atrial Septal Puncture Needle | Hangzhou Nuosheng Medical Technology Co., Ltd. | 2024-6-7 | Zhejiang | CN Medical Device Registration No. 20243011095 |
273 | Fundus Disease Fundus Image Auxiliary Diagnosis Software | Beijing Zhiyuan Huitu Technology Co., Ltd. | 2024-6-18 | Beijing | CN Medical Device Registration No. 20243211109 |
274 | Needle for Bronchial Navigation Operation Control System | IntuitiveSurgical | 2024-6-19 | United States | China Medical Device Registration No. 20242020316 |
275 | Cryogenic Ablation System | Shanghai Antech Medical Technology Co., Ltd. | 2024-7-4 | Shanghai | China Medical Device Registration No. 20243011210 |
276 | Single-Use Cardiac Pulsed Field Ablation Catheter | FARAPULSE,Inc. | 2024-7-4 | United States | China Medical Device Registration No. 20243010355 |
277 | Cardiac Pulsed Field Ablation System | FARAPULSE,Inc. | 2024-7-4 | United States | CN Medical Device Registration Import 20243090354 |
278 | Iliac Vein Stent System | Hangzhou Weiqiang Medical Technology Co., Ltd. | 2024-7-11 | Zhejiang | China Medical Device Registration Certificate No. 20243131244 |
279 | Single-Use Intracardiac Echocardiography Imaging Catheter | Shenzhen Saihe Medical Technology Co., Ltd. | 2024-7-17 | Guangdong | China Medical Device Registration No. 20243061274 |
280 | Portable Ultrasound Diagnostic Device | Shenzhen Saihe Medical Technology Co., Ltd. | 2024-7-17 | Guangdong | CN Medical Device Registration No. 20243061271 |
281 | Disposable Adjustable Bend Catheter Sheath | FARAPULSE,Inc. | 2024-7-24 | United States | CN Medical Device Registration Import 20243030396 |
282 | Bioabsorbable Rapamycin-Eluting Coronary Stent System | Shanghai MicroPort Medical (Group) Co., Ltd. | 2024-7-30 | Shanghai | China Medical Device Registration No. 20243131356 |
283 | Renal Artery Radiofrequency Ablation Device | Suzhou X-Med Medical Device Co., Ltd. | 2024-8-5 | Jiangsu | China Medical Device Registration No. 20243011383 |
284 | Disposable Renal Artery Radiofrequency Ablation Catheter | Suzhou Xindai Medical Device Co., Ltd. | 2024-8-5 | Jiangsu | China Medical Device Registration Certificate No. 20243011384 |
285 | Renal Artery Radiofrequency Ablation Device | Shanghai Medtronic Weiye Medical Technology Co., Ltd. | 2024-8-5 | Shanghai | CN Medical Device Registration No. 20243011387 |
286 | Disposable Mesh Renal Artery Radiofrequency Ablation Catheter | Shanghai MarvelLeaf Medical Technology Co., Ltd. | 2024-8-5 | Shanghai | CN Medical Device Registration No. 20243011385 |
287 | Balloon Cryoablation Catheter | Shanghai Atech Medical Technology Co., Ltd. | 2024-8-5 | Shanghai | CN Medical Device Registration No. 20243011414 |
288 | Transcatheter Aortic Valve System | Shanghai NewMed Medical Technology Co., Ltd. | 2024-8-14 | Shanghai | China Medical Device Registration Certificate 20243131459 |
289 | Venous Stent System | Shanghai Lanmai Medical Technology Co., Ltd. | 2024-8-22 | Shanghai | China Medical Device Registration No. 20243131528 |
290 | Transcatheter Aortic Valve System | Beijing Balloon Medical Technology Co., Ltd. | 2024-8-22 | Beijing | China Medical Device Registration Certificate 20243131529 |
291 | Vascular Plaque Rotablation Control Device | Boston Scientific Corporation | 2024-8-22 | United States | China Medical Device Registration No. 20243010448 |
292 | Single-Use Peripheral Vascular Plaque Excision Catheter | Boston Scientific Corporation | 2024-8-22 | United States | CN Medical Device Registration Import 20243010449 |
293 | Hepatitis B Virus Surface Antigen (HBsAg) Detection Kit | Fujirebio Inc. | 2024-8-30 | Japan | CN Medical Device Registration Import 20243400480 |
294 | Navigation and Positioning Microwave Ablation System | True Health (Zhuhai) Medical Technology Co., Ltd. | 2024-8-30 | Guangdong | CN Medical Device Registration No. 20243011651 |
