Shanghai MicroPort's Bioresorbable Rapamycin-Eluting Coronary Stent System Approved as 282nd Innovative Medical Device in China
MicroPort
High-end Medical Device R&D and Manufacturer
On July 30, the National Medical Products Administration announced that the "Bioabsorbable Rapamycin-Eluting Coronary Stent System" produced by Shanghai MicroPort Medical (Group) Co., Ltd. has been approved for marketing, becoming the 282nd innovative medical device product to be approved for sale in China.
Recently, the National Medical Products Administration approved the innovative product registration application of "Bioabsorbable Rapamycin-Eluting Coronary Stent System" by Shanghai MicroPort Medical (Group) Co., Ltd.
This product consists of a drug-eluting stent and a delivery system. The stent is composed of three parts: the stent body, radiopaque markers, and a drug coating. The stent body is made of poly-L-lactic acid (PLLA), with one radiopaque marker at each end of the stent. The sirolimus drug coating is sprayed on the outer surface of the stent. The delivery system is a rapid exchange balloon dilation catheter. This product is sterilized by irradiation, for single use, to improve the internal diameter of the coronary artery, and is suitable for patients with ischemic heart disease caused by primary coronary artery lesions.
This product adopts a single-sided drug coating technology, applying the drug only to the outer surface of the stent through a spot-coating process. The sides and inner surface of the stent struts are free of drug coating, which improves drug utilization and facilitates the vascular endothelialization process.
The drug regulatory department will strengthen the post-marketing supervision of this product to protect the safety of patients using medical devices.
Serial Number | Product Name | Manufacturer | Approval Date | Location | Registration Certificate No. |
1 | Gene Sequencer | Shenzhen Hyk Gene Technology Co., Ltd. | 2014-12-10 | Guangdong | China Medical Device Registration Certificate No. 20143402171 |
2 | Isothermal Amplification Microfluidic Chip Nucleic Acid Analyzer | CapitalBio Corporation | 2015-4-20 | Beijing | China Medical Device Registration Certificate No. 20153400580 |
3 | Dual-Channel Implantable Deep Brain Stimulation Pulse Generator Kit | Suzhou JY Medical Device Co., Ltd. | 2015-6-9 | Jiangsu | China Medical Device Registration Certificate No. 20153210970 |
4 | Implantable Deep Brain Stimulation Electrode Lead Kit | Suzhou Jingtai Medical Device Co., Ltd. | 2015-6-9 | Jiangsu | China Medical Device Registration No. 20153210971 |
5 | Implantable Deep Brain Stimulation Extension Lead Kit | Suzhou Jingtai Medical Device Co., Ltd. | 2015-6-9 | Jiangsu | China Medical Device Registration Certificate No. 20153210972 |
6 | MTHFR C677T Gene Detection Kit (PCR-Gold Magnetic Particle Chromatography) | Xi'an JinCi Nano Biotechnology Co., Ltd. | 2015-7-3 | Shaanxi | China Medical Device Registration No. 20153401148 |
7 | Decellularized Corneal Stroma | Shenzhen Ainier Corneal Engineering Co., Ltd. | 2015-4-22 | Guangdong | China Medical Device Registration No. 20153460581 |
8 | Septin9 Gene Methylation Detection Kit (PCR Fluorescence Probe Method) | Borcheng (Beijing) Technology Co., Ltd. | 2015-8-24 | Beijing | China Medical Device Registration Certificate No. 20153401481 |
9 | Digital Breast Tomosynthesis System | Conning (Tianjin) Medical Equipment Co., Ltd. | 2015-11-20 | Tianjin | China Medical Device Registration No. 20153302052 |
10 | Survival Motor Neuron 1 (SMN1) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method) | Shanghai Wuse Stone Medical Research Co., Ltd. | 2015-12-22 | Shanghai | China Medical Device Registration No. 20153402293 |
11 | 3D Cardiac Electrophysiology Mapping System | Shanghai MicroPort Electrophysiology Medical Technology Co., Ltd. | 2016-2-26 | Shanghai | China Medical Device Registration Certificate 20163770387 |
12 | Respiratory Pathogen Nucleic Acid Detection Kit (Isothermal Amplification Chip Method) | CapitalBio Corporation | 2016-2-17 | Beijing | China Medical Device Registration Certificate No. 20163400327 |
13 | Decellularized Corneal Graft | Guangzhou UDC Biotechnology Co., Ltd. | 2016-3-28 | Guangdong | China Medical Device Registration No. 20163460573 |
14 | Implantable Vagus Nerve Stimulation Pulse Generator Kit | Beijing PINS Medical Co., Ltd. | 2016-5-16 | Beijing | China Medical Device Registration No. 20163210989 |
15 | Implantable Vagus Nerve Stimulation Electrode Lead Kit | Beijing PINS Medical Co., Ltd. | 2016-5-16 | Beijing | China Medical Device Registration Certificate No. 20163210990 |
16 | Drug-Eluting Peripheral Balloon Dilatation Catheter | Beijing Cercare Medical Technology Co., Ltd. | 2016-5-25 | Beijing | China Medical Device Registration No. 20163771020 |
17 | Cold Saline Irrigation Radiofrequency Ablation Catheter | Shanghai MicroPort Electrophysiology Medical Technology Co., Ltd. | 2016-5-31 | Shanghai | China Medical Device Registration Certificate No. 20163771040 |
18 | Sternum Plate | Changzhou Huasen Medical Instrument Co., Ltd. | 2016-10-8 | Jiangsu | China Medical Device Registration No. 20163461582 |
19 | Positron Emission and X-ray Computed Tomography Imaging Device | Mingfeng Medical Systems Co., Ltd. | 2016-10-17 | Zhejiang | China Medical Device Registration No. 20163332156 |
20 | Intraocular Lens | Aiborn (Beijing) Medical Technology Co., Ltd. | 2016-11-21 | Beijing | China Medical Device Registration No. 20163221747 |
21 | Orthopedic Surgical Navigation and Positioning System | Beijing Tinavi Medical Technologies Co., Ltd. | 2016.11.14 | Beijing | China Medical Device Registration Certificate No. 20163542280 |
22 | Cryoablation Surgery System | HaiJieYa (Beijing) Medical Device Co., Ltd. | 2017-2-14 | Beijing | NMPA Registration Approval 20173583088 |
23 | Disposable Sterile Cryoablation Needle | HaiJieYa (Beijing) Medical Device Co., Ltd. | 2017-2-14 | Beijing | China Medical Device Registration No. 20173583089 |
24 | Variable-angle Dual-detector Single Photon Emission Computed Tomography (SPECT) Device | Beijing Yongxin Medical Equipment Co., Ltd. | 2017-4-26 | Beijing | China Medical Device Registration Certificate No. 20173330681 |
25 | Fully Degradable Nasal Sinus Drug Stent System | Puyi (Shanghai) Biotechnology Co., Ltd. | 2017-4-25 | Shanghai | China Medical Device Registration Certificate No. 20173460679 |
26 | Percutaneous Interventional Artificial Heart Valve System | Hangzhou Qiming Medical Device Co., Ltd. | 2017-4-25 | Zhejiang | China Medical Device Registration Certificate 20173460680 |
27 | Transcatheter Bioprosthetic Heart Valve | Suzhou Jiecheng Medical Technology Co., Ltd. | 2017-4-28 | Jiangsu | China Medical Device Registration No. 20173460698 |
28 | Disposable Absorbable Stapler for Intradermal Anastomosis | Beijing Yihe Hengrui Medical Technology Co., Ltd. | 2017-5-31 | Beijing | China Medical Device Registration No. 20173650874 |
29 | Left Atrial Appendage Occluder System | Lifetech Scientific (Shenzhen) Co., Ltd. | 2017-6-2 | Guangdong | China Medical Device Registration Certificate No. 20173770881 |
30 | Branched Aortic Stent Graft and Delivery System | Shanghai MicroPort Medical (Group) Co., Ltd. | 2017-6-26 | Shanghai | China Medical Device Registration Certificate 20173463241 |
31 | Foldable Artificial Vitreous Balloon | Guangzhou Weishi Bo Biotechnology Co., Ltd. | 2017-7-25 | Guangdong | China Medical Device Registration Certificate 20173223296 |
32 | Abdominal Aortic Stent Graft System | Beijing Huamai Taik Medical Device Co., Ltd. | 2017-10-17 | Beijing | China Medical Device Registration Certificate 20173461434 |
33 | Implantable Cardiac Pacemaker | LifeTech Scientific (Shenzhen) Co., Ltd. | 2017-12-11 | Guangdong | China Medical Device Registration Certificate No. 20173211570 |
34 | Human EGFR Gene Mutation Detection Kit (Multiplex Fluorescence PCR Method) | Xiamen Amoy Diagnostics Co., Ltd. | 2018-1-18 | Fujian | China Medical Device Registration No. 20183400014 |
35 | Absorbable Dural Sealant Medical Adhesive | Shandong Saikesaisi Pharmaceutical Technology Co., Ltd. | 2018-1-25 | Shandong | China Medical Device Registration No. 20183650031 |
36 | Vascular Reconstruction Device | MicroPort ShenTong Medical Technology (Shanghai) Co., Ltd. | 2018-3-15 | Shanghai | China Medical Device Registration Certificate No. 20183770102 |
37 | miR-92a Detection Kit (Fluorescence RT-PCR Method) | Shenzhen Jinbaihui Bio Co., Ltd. | 2018-3-27 | Guangdong | China Medical Device Registration No. 20183400108 |
38 | Hepatitis C Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probe Method) | Beijing Najie Diagnostic Reagent Co., Ltd. | 2018-4-20 | Beijing | China Medical Device Registration No. 20183400157 |
39 | Cerebral Thrombectomy Device | Jiangsu Nico Medical Device Co., Ltd. | 2018-5-08 | Jiangsu | China Medical Device Registration No. 20183770186 |
40 | Quantitative Flow Ratio Measurement System | Pulse Medical Imaging Technology (Shanghai) Co., Ltd. | 2018-7-12 | Shanghai | China Medical Device Registration No. 20183210282 |
41 | Human EGFR/ALK/BRAF/KRAS Gene Mutation Combined Detection Kit (Reversible Terminator Sequencing Method) | Guangzhou Burning Rock Medical Inspection Co., Ltd. | 2018-7-18 | Guangdong | China Medical Device Registration No. 20183400286 |
42 | Fully Automatic Chemiluminescence Immunoassay Analyzer | Beijing United Tech Co., Ltd. | 2018-8-11 | Beijing | NMPA Registration Approval 20183220293 |
43 | Human EGFR, KRAS, BRAF, PIK3CA, ALK, ROS1 Gene Mutation Detection Kit (Semiconductor Sequencing Method) | Tianjin Novogene Bioinformatics Technology Co., Ltd. | 2018-8-11 | Tianjin | NMPA Registration Certificate 20183400294 |
44 | Composite Hernia Repair Patch | Shanghai Songli Biotechnology Co., Ltd. | 2018-8-12 | Shanghai | China Medical Device Registration Certificate 20183130292 |
45 | Positron Emission Tomography and Magnetic Resonance Imaging System | Shanghai United Imaging Healthcare Co., Ltd. | 2018-8-29 | Shanghai | NMPA Registration Approval 20183060337 |
46 | EGFR/ALK/ROS1/BRAF/KRAS/HER2 Gene Mutation Detection Kit (Reversible Terminator Sequencing Method) | Nanjing Shihew Medical Device Co., Ltd. | 2018-9-28 | Jiangsu | China Medical Device Registration Certificate No. 20183400408 |
47 | Implantable Sacral Nerve Stimulation Electrode Lead Kit | Beijing PINS Medical Co., Ltd. | 2018-9-28 | Beijing | China Medical Device Registration Certificate 20183120409 |
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 |
50 | Human 10-Gene Mutation Combined Detection Kit (Reversible Terminator Sequencing Method) | Xiamen Amoy Diagnostics Co., Ltd. | 2018-11-16 | Fujian | China Medical Device Registration No. 20183400507 |
51 | Medical Electronic Linear Accelerator | Guangdong Zhongneng Accelerator Technology Co., Ltd. | 2018-11-28 | Guangdong | China Medical Device Registration Certificate 20183050520 |
52 | Valve Annuloplasty Ring | Jinshi Biotechnology (Changshu) Co., Ltd. | 2018-12-07 | Jiangsu | China Medical Device Registration Certificate No. 20183130534 |
53 | Neurosurgical Navigation and Positioning System | Huake Precision (Beijing) Medical Technology Co., Ltd. | 2018-12-21 | Beijing | China Medical Device Registration Certificate 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 Certificate 20193130001 |
56 | Bioabsorbable Coronary Sirolimus-Eluting Stent System | Lepu (Beijing) Medical Device Co., Ltd. | 2019-2-22 | Beijing | China Medical Device Registration Certificate No. 20193130093 |
57 | Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-3-12 | Guangdong | China Medical Device Registration Certificate No. 20193070154 |
58 | Abdominal Aortic Stent Graft and Delivery System | MicroPort CardioTech (Shanghai) Co., Ltd. | 2019-3-19 | Shanghai | China Medical Device Registration Certificate No. 20193130182 |
59 | Left Atrial Appendage Closure System | Beijing MDT Medical Technology Co., Ltd. | 2019-4-30 | Beijing | China Medical Device Registration Certificate No. 20193130278 |
60 | Left Atrial Appendage Occluder System | Shanghai Pushi Medical Technology Co., Ltd. | 2019-5-5 | Shanghai | China Medical Device Registration Certificate 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 |
62 | Digital Breast X-ray Photography System | Shanghai United Imaging Healthcare Co., Ltd. | 2019-5-6 | Shanghai | China Medical Device Registration Certificate 20193060280 |
63 | Positron Emission and X-ray Computed Tomography Imaging System | Hubei Ray-Scan Digital Medical Imaging Technology Co., Ltd. | 2019-5-31 | Hubei | National Medical Device Registration Approval 20193060364 |
64 | Micra Transcatheter Leadless Pacemaker System | Medtronic Medtronic Inc. | 2019-6-11 | United States | China Medical Device Registration No. 20193120297 |
65 | Transcatheter Aortic Valve System | Shanghai MicroPort CardioFlow Medtech Co., Ltd. | 2019-7-10 | Shanghai | China Medical Device Registration Certificate No. 20193130494 |
66 | Single-Use Intravascular Imaging Catheter | Nanjing Woforman Medical Technology Co., Ltd. | 2019-8-19 | Jiangsu | China Medical Device Registration Certificate No. 20193060601 |
67 | Non-invasive Blood Glucose Meter | Bobiang Fangzhou Medical Technology (Beijing) Co., Ltd. | 2019-8-26 | Beijing | China Medical Device Registration Certificate 20193070602 |
68 | Implantable Left Ventricular Assist System | Chongqing Yongrenxin Medical Device Co., Ltd. | 2019-8-26 | Chongqing | China Medical Device Registration Certificate 20193120603 |
69 | Decellularized Corneal Graft | Qingdao Zhonghao Bioengineering Co., Ltd. | 2019-9-12 | Shandong | China Medical Device Registration Certificate No. 20193160679 |
70 | Coronary Angiography Flow Reserve Fraction Measurement System | Suzhou Runmed Medical Technology Co., Ltd. | 2019-12-09 | Jiangsu | China Medical Device Registration No. 20193070969 |
71 | Disposable Invasive Pressure Sensor | Suzhou Runmed Medical Technology Co., Ltd. | 2019-12-9 | Jiangsu | China Medical Device Registration Certificate No. 20193070970 |
72 | Positron Emission and X-ray Computed Tomography Imaging System | Shanghai United Imaging Healthcare Co., Ltd. | 2019-12-17 | Shanghai | China Medical Device Registration Certificate No. 20193060998 |
73 | Nucleic Acid Amplification Testing Analyzer | Hangzhou YouSiDa Biotechnology Co., Ltd. | 2019-12-23 | Zhejiang | China Medical Device Registration No. 20193061026 |
74 | Puncture Surgery Navigation Equipment | Medatrax Medical Technology (Suzhou) Co., Ltd. | 2020-01-14 | Jiangsu | China Medical Device Registration Certificate No. 20203010034 |
75 | Coronary Flow Reserve Fraction Calculation Software | Beijing Kunlun Medical Cloud Technology Co., Ltd. | 2020-01-14 | Beijing | China Medical Device Registration No. 20203210035 |
76 | Human EGFR/KRAS/BRAF/HER2/ALK/ROS1 Gene Mutation Detection Kit (Semiconductor Sequencing Method) | Xiamen Fisrt Bio-Technology Co., Ltd. | 2020-01-22 | Fujian | China Medical Device Registration Certificate No. 20203400094 |
77 | Pre-implantation Chromosome Aneuploidy Detection Kit (Semiconductor Sequencing Method) | Suzhou Beikang Medical Equipment Co., Ltd. | 2020-02-21 | Jiangsu | China Medical Device Registration Certificate No. 20203400181 |
78 | Bioabsorbable Coronary Rapamycin-Eluting Stent System | Shandong Hu'an Biotechnology Co., Ltd. | 2020-3-4 | Shandong | China Medical Device Registration No. 20203130197 |
79 | Drug-Coated Balloon Dilatation Catheter | Shanghai MicroPort CardioFlow Medtech Co., Ltd. | 2020-4-26 | Shanghai | China Medical Device Registration No. 20203130445 |
80 | Cardiovascular Optical Coherence Tomography Equipment and Accessories | Shenzhen Zhongke MicroLight Medical Device Technology Co., Ltd. | 2020-04-28 | Guangdong | China Medical Device Registration Certificate No. 20203060446 |
81 | RNF180/Septin9 Gene Methylation Detection Kit (PCR Fluorescence Probe Method) | Borcheng (Beijing) Technology Co., Ltd. | 2020-04-28 | Beijing | China Medical Device Registration Certificate No. 20203400447 |
82 | Plasma Surgical Device | Hunan Jingyi Medical Technology Co., Ltd. | 2020-05-08 | Hunan | CN Medical Device Registration No. 20203010474 |
83 | Tumor Electric Field Therapy Device | NovoCure Ltd. | 2020-05-11 | Israel | China Medical Device Registration No. 20203090269 |
84 | Transcatheter Aortic Valve System | Edwards Lifesciences LLC | 2020-06-05 | United States | China Medical Device Registration No. 20203130291 |
85 | Transcatheter Mitral Valve Clip and Steerable Guiding Catheter | Abbott Vascular | 2020-06-15 | United States | China Medical Device Registration No. 20203130325 |
86 | Diabetic Retinopathy Analysis Software | Shanghai Eagle Eye Medical Technology Co., Ltd. | 2020-08-07 | Shanghai | China Medical Device Registration No. 20203210686 |
87 | Diabetic Retinopathy Fundus Image Auxiliary Diagnosis Software | Shenzhen Guiji Intelligent Technology Co., Ltd. | 2020-08-07 | Guangdong | China Medical Device Registration No. 20203210687 |
88 | Coated Hip Joint Ball Head | China AooHuiCheng Technology Co., Ltd. | 2020-08-20 | Beijing | China Medical Device Registration Certificate No. 20203130707 |
89 | Thrombectomy Stent | Zhuhai Tongqiao Medical Technology Co., Ltd. | 2020-09-07 | Guangdong | China Medical Device Registration Certificate No. 20203030728 |
90 | Fractional Flow Reserve Measurement Device | Shenzhen Northcore Life Science and Technology Co., Ltd. | 2020-09-29 | Guangdong | China Medical Device Registration Certificate No. 20203070774 |
91 | Pressure Microcatheter | Shenzhen NorthCore Life Science Co., Ltd. | 2020-09-29 | Guangdong | China Medical Device Registration Certificate No. 20203070775 |
92 | Hydrogen-Oxygen Nebulizer | Shanghai Humed Medical Technology Co., Ltd. | 2020-02-02 | Shanghai | China Medical Device Registration Certificate No. 20203080066 |
93 | Memory Alloy Nail Foot Fixator | Lanzhou Xipulse Memory Alloy Co., Ltd. | 2020.10.26 | Gansu | China Medical Device Registration Certificate No. 20203130823 |
94 | Coronary CT Angiography Image Vessel Stenosis Auxiliary Triage Software | Yukun (Beijing) Network Technology Co., Ltd. | 2020-11-03 | Beijing | China Medical Device Registration Certificate No. 20203210844 |
95 | KRAS Gene Mutation and BMP3/NDRG4 Gene Methylation and Fecal Occult Blood Combined Detection Kit (PCR Fluorescence 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 | China Medical Device Registration Certificate No. 20203030857 |
97 | Peripheral Nerve Repair Graft | Jiangsu Yitong Bio-Technology Co., Ltd. | 2020.11.17 | Jiangsu | China Medical Device Registration Certificate No. 20203130898 |
98 | CT Imaging Pulmonary Nodule Auxiliary Detection Software | Hangzhou DeepRui BoLian Technology Co., Ltd. | 2020-11-30 | Zhejiang | China Medical Device Registration Certificate No. 20203210920 |
99 | Vertebral Artery Rapamycin-Eluting Stent System | MicroPort ShenTong Medical Technology (Shanghai) Co., Ltd. | 2020-12-17 | Shanghai | China Medical Device Registration Certificate No. 20203130971 |
100 | Iliac Artery Bifurcation Stent System | LifeTech (Shenzhen) Co., Ltd. | 2021-1-12 | Guangdong | China Medical Device Registration Certificate No. 20213130022 |
101 | Balloon Dilatation 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 | China Medical Device Registration Certificate No. 20213060169 |
103 | Single-Use Electronic Ureteroscopic Nephroscope | Beijing Beifang Tengda Technology Development Co., Ltd. | 2021-3-16 | Beijing | China Medical Device Registration Certificate No. 20213060175 |
104 | Helicobacter pylori 23S rRNA Gene Mutation Detection Kit (PCR-Fluorescence Probe Method) | Shanghai Xinhao 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 Certificate 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 | CN Medical Device Registration Approval 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 | MicroPort (Shanghai) Medical Robotics Co., Ltd. | 2021-6-4 | Shanghai | China Medical Device Registration Certificate No. 20213060384 |
111 | Transcatheter Aortic Valve System | Peijia Medical Technology (Suzhou) Co., Ltd. | 2021-6-24 | Jiangsu | China Medical Device Registration No. 20213130464 |
112 | Self-expanding Intracranial Aneurysm Occlusion 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 | CN Med Dev Reg 20213090497 |
114 | Coronary CT Blood Flow Reserve Fraction Calculation Software | Beijing Xinshiji Medical Technology Co., Ltd. | 2021-7-29 | Beijing | China Medical Device Registration Certificate 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 | China Medical Device Registration No. 20213130594 |
117 | Unicompartmental Knee Prosthesis | Beijing Chunli Zhengda Medical Device Co., Ltd. | 2021-8-6 | Beijing | China Medical Device Registration Certificate No. 20213130600 |
118 | Endoscopic Ultrasound Diagnostic Equipment | Shenzhen InnovMedical 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 | China Medical Device Registration Certificate 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 | China Medical Device Registration Certificate No. 20213010713 |
122 | Disposable Hydrodynamic Debridement Blade | Huizhou Haizhuokosai Medical Co., Ltd. | 2021-9-27 | Guangdong | CN Medical Device Registration Approval 20213010779 |
123 | Hydrodynamic Therapy Device | Huizhou Haizhuokosai Medical Co., Ltd. | 2021-9-27 | Guangdong | China Medical Device Registration No. 20213010780 |
124 | Medical Electron Linear Accelerator | Suzhou Leitai Medical Technology Co., Ltd. | 2021-10-9 | Jiangsu | China Medical Device Registration Certificate No. 20213050789 |
125 | Balloon-Expandable Vascular Stent-Graft System | W.L. Gore & Associates, Inc. | 2021-10-19 | United States | China Medical Device Registration No. 20213130411 |
126 | Intraperitoneal Endoscopic Surgical Equipment | Shandong Weigao Surgical Robotics Co., Ltd. | 2021-10-26 | Shandong | China 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 | CN Medical Device Registration No. 20213070872 |
130 | Biological Hernia Repair Patch | ZhuoRuan Medical Technology (Suzhou) Co., Ltd. | 2021-11-8 | Jiangsu | China Medical Device Registration Certificate 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 Mihe Medical Device Co., Ltd. | 2021-12-3 | Beijing | China Medical Device Registration No. 20213161017 |
133 | Branched Intraoperative Stent System | Shanghai MicroPort CardioFlow Medtech Corp. | 2021-12-14 | Shanghai | China Medical Device Registration No. 20213131059 |
134 | Transcatheter Aortic Valve System | MEDTRONIC INC. | 2021-12-24 | United States | China Medical Device Registration No. 20213130538 |
135 | Implantable Rechargeable Spinal Cord Neurostimulator | Beijing PINS Medical Co., Ltd. | 2022-1-10 | Beijing | China Medical Device Registration No. 20223120019 |
136 | Implantable Spinal Cord Neurostimulator | Beijing PINS Medical Co., Ltd. | 2022-1-10 | Beijing | China Medical Device Registration Certificate No. 20223120020 |
137 | Implantable Spinal Cord Neurostimulation Electrode | Beijing PINS Medical Co., Ltd. | 2022-1-10 | Beijing | China Medical Device Registration Certificate No. 20223120021 |
138 | Implantable Spinal Cord Neurostimulation Extension Lead | Beijing PINS Medical Co., Ltd. | 2022-1-10 | Beijing | China Medical Device Registration Certificate 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 | China Medical Device Registration Certificate No. 20223010024 |
141 | Straight-tube Thoracic Aortic Stent Graft System | Shanghai MicroPort CardioFlow Medtech (Group) Co., Ltd. | 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 Certificate 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 | China 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 Certificate No. 20223120087 |
146 | Intraperitoneal Endoscopic Surgical System | Shanghai MicroPort Medical Robot (Group) Co., Ltd. | 2022-1-25 | Shanghai | China Medical Device Registration Certificate 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 Ruijia Tu Medical Technology Co., Ltd. | 2022-3-2 | Guangdong | China Medical Device Registration No. 20223060289 |
149 | Intracranial Hemorrhage CT Image Auxiliary Triage Software | Shanghai United Imaging Intelligence Healthcare Technology Co., Ltd. | 2022-3-9 | Shanghai | China Medical Device Registration Certificate No. 20223210309 |
150 | Magnetic Resonance Imaging System | Xingaoyi Medical Equipment Co., Ltd. | 2022-4-2 | Zhejiang | CN Medical Device Registration Approval 20223060431 |
151 | Hip Joint Replacement Surgery Navigation and Positioning System | Hangzhou Jianjia Robotics Co., Ltd. | 2022-4-6 | Zhejiang | China Medical Device Registration Certificate No. 20223010462 |
152 | Knee Joint Replacement Surgery Navigation and Positioning System | Suzhou MicroPort Changxing Robotics Co., Ltd. | 2022-4-20 | Jiangsu | China Medical Device Registration No. 20223010509 |
153 | Spinal Cord Stimulation Test Electrode | Beijing PINS Medical Co., Ltd. | 2022-4-20 | Beijing | China Medical Device Registration Certificate No. 20223120511 |
154 | Knee Joint Replacement Surgery Navigation and Positioning System | OrthoBot Robotics (Shenzhen) Co., Ltd. | 2022-4-20 | Guangdong | China Medical Device Registration No. 20223010510 |
155 | Iliac Vein Stent System | Suzhou Tianhong Shengjie Medical Device Co., Ltd. | 2022-4-20 | Jiangsu | China Medical Device Registration Certificate No. 20223130512 |
156 | Transcatheter Implantable Leadless Pacing System | Medtronic Inc. Medtronic | 2022-5-11 | United States | China Medical Device Registration No. 20223120231 |
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 | CN Med Dev Reg Cert 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 Krypton Health Technology Co., Ltd. | 2022-6-2 | Beijing | China Medical Device Registration No. 20223060721 |
162 | Disposable 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 Kandu Robotics Co., Ltd. | 2022-6-24 | Jiangsu | China Medical Device Registration Certificate 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 | CN Medical Device Registration No. 20223120892 |
166 | Gamma Beam Stereotactic Radiosurgery System | Xi'an Dali Medical Group Co., Ltd. | 2022-7-13 | Shaanxi | CN Medical Device Registration No. 20223050891 |
167 | Dual-source Cone Beam Computed Tomography Equipment for ENT | Beijing Longvision Instruments Co., Ltd. | 2022-7-19 | Beijing | China Medical Device Registration No. 20223060951 |
168 | Single-Use Intravascular Ultrasound Diagnostic Catheter | Shenzhen Northcore Life Technology Co., Ltd. | 2022-7-25 | Guangdong | China Medical Device Registration No. 20223060974 |
169 | Intravascular Ultrasound Diagnostic Instrument | Shenzhen Northcore Life Technology Co., Ltd. | 2022-7-25 | Guangdong | China Medical Device Registration No. 20223060975 |
170 | Electronic Colonoscopy Image-Assisted Detection Software for Colonic Polyps | Chengdu MicroRecognition Medical Device Co., Ltd. | 2022-8-2 | Sichuan | China 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 | CN Med Device Reg. No. 20223400387 |
173 | Anastomotic Reinforcement Patch | Beijing Bohui Ruijin Biotechnology Co., Ltd. | 2022-8-3 | Beijing | China Medical Device Registration Certificate No. 20223130983 |
174 | Medical Adhesive | Hangzhou Yahui Biotechnology Co., Ltd. | 2022-8-29 | Zhejiang | China Medical Device Registration Certificate 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 No. 20223211140 |
176 | Magnetic Resonance Imaging System | Shanghai United Imaging Healthcare Co., Ltd. | 2022-8-31 | Shanghai | China Medical Device Registration No. 20223061141 |
177 | Umibilim Coated Coronary Balloon Dilatation Catheter | Shandong Jiwei Medical Products Co., Ltd. | 2022-9-19 | Shandong | China Medical Device Registration Certificate 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 Intelligence Creation (Beijing) Technology Co., Ltd. | 2022-10-11 | Beijing | China Medical Device Registration Certificate 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 | Aibonuo (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 Certificate 20223131515 |
185 | Single-Use Pressure Monitoring Magnetic Localization RF Ablation Catheter | Shanghai MicroPort Electrophysiology Medical Technology Co., Ltd. | 2022-12-01 | Shanghai | China Medical Device Registration Certificate 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 Technologies 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 Certificate No. 20223061659 |
189 | Medical Vascular Angiography X-ray Machine | Shanghai United Imaging Healthcare Co., Ltd. | 2022-12-30 | Shanghai | China Medical Device Registration Certificate No. 20223061821 |
190 | Patient Monitor | Shenzhen Comen Medical Devices Co., Ltd. | 2023-1-5 | Guangdong | China Medical Device Registration No. 20233070003 |
191 | Hybrid Closed-Loop Insulin Delivery System | Medtronic MiniMed | 2023-2-27 | United States | CN Medical Device Registration Import 20233140061 |
192 | Hemodialysis Urea Clearance Calculation Software | Beijing Infomagic Information Technology Co., Ltd. | 2023-2-27 | Beijing | CN Med Approval 20233210219 |
193 | Collagen Cartilage Repair Scaffold | Ubiosis Co., Ltd | 2023-4-4 | Korea | Registration Certificate for Imported Medical Devices: 20233130129 |
194 | Magnetic Resonance-Guided Semiconductor Laser Therapy Device | Huake Precision (Beijing) Medical Technology Co., Ltd. | 2023-4-4 | Beijing | China Medical Device Registration No. 20233010449 |
195 | Coronary CT Blood Flow Reserve Fraction Calculation Software | Shanghai BoLuo Medical Technology Co., Ltd. | 2023-4-4 | Shanghai | China Medical Device Registration Certificate 20233210450 |
196 | Disposable Laser Fiber Kit | Huake Precision (Beijing) Medical Technology Co., Ltd. | 2023-4-13 | Beijing | CN Med Approval 20233010485 |
197 | Intraocular Lens | Alcon Laboratories, Incorporated | 2023-4-17 | United States | China Medical Device Registration No. 20233160146 |
198 | Coronary Artery Function Measurement System | Suzhou Runmed Medical Technology Co., Ltd. | 2023-4-20 | Jiangsu | China Medical Device Registration No. 20233070520 |
199 | Metal Additive Manufacturing Thoracolumbar Fusion Matched Prosthesis System | Beijing Aikang Yicheng Medical Devices Co., Ltd. | 2023-4-21 | Beijing | China Medical Device Registration Certificate No. 20233130524 |
200 | Self-expanding Particle-loaded Biliary Stent | Nanjing Rongsheng Medical Technology Co., Ltd. | 2023-5-11 | Jiangsu | China Medical Device Registration No. 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 No. 20233210629 |
202 | Intravascular Imaging Device | Conavi Medical Inc. | 2023-5-16 | Canada | China Medical Device Registration No. 20233060200 |
203 | Radiotherapy Planning Software | Shanghai United Imaging Healthcare Co., Ltd. | 2023-5-23 | Shanghai | CN Medical Device Registration No. 20233210665 |
204 | Electronic Endoscopic Image-Assisted Detection Software for Colonic Polyps | Tencent Medical Health (Shenzhen) Co., Ltd. | 2023-6-1 | Guangdong | CN Medical Device Registration No. 20233210707 |
205 | Disposable Coronary Intervention Surgery Control System Accessories | Corindus Inc. | 2023-6-1 | United States | CN Med Device Reg Cert 20233010226 |
206 | Coronary Interventional Surgery Control System | Corindus Inc. | 2023-6-1 | United States | China Medical Device Registration Import 20233010225 |
207 | Carbon Ion Therapy System | Lanzhou Kejin Taiji New Technology Co., Ltd. | 2023-6-2 | Gansu | China Medical Device Registration Certificate No. 20233050708 |
208 | Implantable Left Ventricular Assist System | Shenzhen Core Medical Technology Co., Ltd. | 2023-6-5 | Guangdong | China 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 Certificate 20233120807 |
211 | Implantable Sacral Nerve Stimulation Extension Lead | Hangzhou Chengnuo Medical Technology Co., Ltd. | 2023-6-14 | Zhejiang | China Medical Device Registration Certificate 20233120808 |
212 | Implantable Sacral Nerve Stimulation Electrode | Hangzhou Chengnuo Medical Technology Co., Ltd. | 2023-6-14 | Zhejiang | China Medical Device Registration Certificate 20233120809 |
213 | Puncture Surgery Navigation and Positioning System | True Health (Beijing) Medical Technology Co., Ltd. | 2023-6-15 | Beijing | China Medical Device Registration Certificate No. 20233010810 |
214 | Zirconium Niobium Alloy Femoral Head | Suzhou MicroPort Joint Medical Technology Co., Ltd. | 2023-6-15 | Jiangsu | China Medical Device Registration Certificate 20233130813 |
215 | Shock Wave Therapy Device | Shenzhen Huikang Precision Instruments Co., Ltd. | 2023-6-20 | Guangdong | China Medical Device Registration Certificate No. 20233090834 |
216 | Single-Port Laparoscopic Surgery System | Beijing Surevy Robotics Co., Ltd. | 2023-6-20 | Beijing | China Medical Device Registration Certificate No. 20233010833 |
217 | Head and Neck X-ray Stereotactic Radiosurgery Treatment System | RuiPu Surgical Systems Co., Ltd. | 2023-6-20 | United States | China Medical Device Registration No. 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 Inloop Medical Device Co., Ltd. | 2023-7-28 | Jiangsu | China Medical Device Registration Certificate No. 20233131034 |
221 | Medical Electron Linear Accelerator | Xi'an Dali Medical Group Co., Ltd. | 2023-8-1 | Shaanxi | China Medical Device Registration Certificate 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 Surgical Navigation and Positioning System | Hangzhou Lancet Robotics Co., Ltd. | 2023-8-10 | Zhejiang | CN Med Device Reg. 20233011155 |
225 | Magnetic Resonance Imaging System | Wuhan Zhongke Polarization Medical Technology Co., Ltd. | 2023-8-16 | Hubei | CN Medical Device Registration Approval 20233061160 |
226 | Intracranial Thrombectomy Stent | Rapid Medical Ltd. | 2023-8-17 | Israel | China Medical Device Registration No. 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 No. 20233131245 |
230 | Mitral Valve Clip System | Shanghai Hanyu Medical Technology Co., Ltd. | 2023-9-7 | Shanghai | China Medical Device Registration Certificate 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 | China Medical Device Registration No. 20233401452 |
232 | X-ray Computed Tomography Equipment | Siemens Healthineers Ltd. 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 Med Device Reg. 20233211543 |
234 | Proton Therapy System | Varian Medical Systems Particle Therapy Co., Ltd. | 2023-11-1 | Germany | China Medical Device Registration Import 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 | China 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 | China Medical Device Registration No. 20233061761 |
240 | Gelatin-Polycaprolactone Layered Gingival Repair Membrane | Nuoyimai'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 | China Medical Device Registration Certificate No. 20233131775 |
242 | Cryogenic Ablation Device | Cryofocus Biotechnology (Shanghai) Co., Ltd. | 2023-12-4 | Shanghai | CN Medical Device Registration No. 20233011815 |
243 | Balloon-type 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 Rosenbot Technology Co., Ltd. | 2023-12-8 | Beijing | China Medical Device Registration Certificate No. 20233011923 |
245 | Biodegradable Magnesium Metal Clips | Suzhou Aoruiji Medical Technology Co., Ltd. | 2023-12-13 | Jiangsu | China 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. | 2023-12-26 | Sichuan | CN Med Approval 20233012053 |
249 | Cardiac Pulsed Field Ablation System | Sichuan Jinjiang Electronic Medical Device Technology Co., Ltd. | 2023-12-26 | Sichuan | China Medical Device Registration No. 20233012051 |
250 | Proton Therapy System | Varian Medical Systems Particle Therapy Co., Ltd. | 2023-12-26 | Germany | China Medical Device Registration No. 20233050613 |
251 | Gastric Bypass Stent System | Hangzhou Tangji Medical Technology Co., Ltd. | 2024-1-17 | Zhejiang | China Medical Device Registration Certificate No. 20243130104 |
252 | IFI44L Gene Methylation Detection Kit (PCR-Melting Curve Method) | Shenzhen Sair Biological Technology Co., Ltd. | 2024-2-5 | Guangdong | CN Med Dev Reg 20243400284 |
253 | CT Angiography Image-Assisted Detection Software for Intracranial Aneurysms | Hangzhou DeepRui BoLian Technology Co., Ltd. | 2024-2-29 | Zhejiang | China Medical Device Registration Certificate No. 20243210396 |
254 | Passive Instruments and Accessories for Bronchoscope Operation Control System | Intuitive Medical | 2024-3-8 | United States | China Medical Device Registration No. 20242080127 |
255 | Single-Use Cardiac Pulsed Field Ablation Catheter | Hangzhou Denovo Electrophysiology Medical Technology Co., Ltd. | 2024-3-8 | Zhejiang | China Medical Device Registration Certificate No. 20243010461 |
256 | Bronchial Navigation Optical Fiber Positioning Catheter Guide | IntuitiveSurgical, Inc. | 2024-3-20 | United States | China Medical Device Registration No. 20242010154 |
257 | Bronchial Navigation Optical Fiber Localization Catheter | IntuitiveSurgical, Inc. | 2024-3-20 | United States | China Medical Device Registration No. 20243010156 |
258 | Bronchial 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 | China Medical Device Registration No. 20243010155 |
260 | Combined Blood Glucose Meter | Jiangsu Jingce Medical Technology Co., Ltd. | 2024-4- | Jiangsu | CN Medical Device Registration No. 20243070662 |
261 | Oligosaccharide Chain Detection Kit (Fluorescent Capillary Electrophoresis Method) | Jiangsu XianSiDa BioTech Co., Ltd. | 2024-4 | Jiangsu | CN Medical Device Registration No. 20243400663 |
262 | Ventricular Assist Device (VAD) | Heart Power Medical (Suzhou) Co., Ltd. | 2024.4.26 | Jiangsu | China Medical Device Registration Certificate No. 20243100773 |
263 | Extracorporeal Ventricular Assist Pump Head and Tubing | HeartPower 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 No. 20243010243 |
266 | Dual-channel Rechargeable Implantable Deep Brain Stimulation Pulse Generator Kit | Beijing PINS Medical Co., Ltd. | 2024.5.23 | Beijing | China Medical Device Registration Certificate No. 20243120979 |
267 | Dual-Channel Implantable Deep Brain Stimulation Pulse Generator Kit | Beijing PINS Medical Co., Ltd. | 2024.5.23 | Beijing | China Medical Device Registration Certificate 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 No. 20243120982 |
270 | Pulmonary Artery Thrombectomy Stent System | Shanghai Tengfu Medical Technology Co., Ltd. | 2024.5.31 | Shanghai | CN Medical Device Registration No. 20243031010 |
271 | Transjugular Intrahepatic Puncture Instrument | Beijing Ailin Medical Technology Co., Ltd. | 2024.5.31 | Beijing | China Medical Device Registration Certificate 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 Lesion Fundus Image Assisted Diagnosis Software | Beijing Zhiyuan Huitu Technology Co., Ltd. | 2024.6.18 | Beijing | China Medical Device Registration Certificate No. 20243211109 |
274 | Needle for Bronchial Navigation Operation Control System | IntuitiveSurgical | 2024.6.19 | United States | China Medical Device Registration Certificate No. 20242020316 |
275 | Cryogenic Ablation System | Shanghai Atech Medical Technology Co., Ltd. | 2024.7.4 | Shanghai | China Medical Device Registration Certificate 20243011210 |
276 | Single-Use Cardiac Pulsed Field Ablation Catheter | FARAPULSE,Inc. | 2024.7.4 | United States | CN Medical Device Registration Import 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 20243131244 |
279 | Single-Use Intracardiac Ultrasound Imaging Catheter | Shenzhen Saihe Medical Technology Co., Ltd. | 2024.7.17 | Guangdong | China Medical Device Registration Certificate 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 Certificate No. 20243131356 |
