Diverse product types:
The medical devices include surgical robots, medical software, artificial organs, stents, and prostheses, covering cardiovascular, neurology, oncology, orthopedics, gastroenterology and other clinical fields.
Outstanding technological innovation:
Most of the products adopt global advanced technologies, such as deep learning, magnetic levitation, additive manufacturing, multimodal imaging, and MR monitoring, which improve the performance, safety and efficiency of the products.
Independent intellectual property:
Some products are the first of their kind in China or leading in the world, such as carbon ion therapy system, implantable left ventricular assist system, implantable sacral nerve stimulation system, and endoscopic single-site surgery system, demonstrating the improvement of China's medical device innovation capability.
High clinical application value:
Most of the products target clinically refractory or highly morbid diseases, such as tumors, medically intractable epilepsy, cerebral arterial thrombosis, and paroxysmal atrial fibrillation, providing new treatment options for patients and helping to improve their survival time and quality of life.
Source: Siyu MedTech (excerpts from article)
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Innovative Medical Devices Approved by NMPA in 2023 |
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Collated by Siyu MedTech |
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SN. |
Product name |
Manufacturer |
Approval date |
Place |
Registration No. |
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1 |
Patient Monitor |
Shenzhen Comen Medical Instruments Co., Ltd. |
2023/1/5 |
Guangdong |
GXZZ 20233070003 |
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2 |
Hybrid Closed-Loop Insulin Delivery System |
Medtronic MiniMed |
2023/2/27 |
USA |
GXZJ 20233140061 |
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3 |
Hemodialysis Urea Clearance Calculation Software |
Beijing IfmSoft Co., Ltd. |
2023/2/27 |
Beijing |
GXZZ 20233210219 |
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4 |
Collagen Scaffold for Cartilage Repair |
Ubiosis Co., Ltd |
2023/4/4 |
South Korea |
GXZJ 20233130129 |
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5 |
Magnetic Resonance Monitoring Semiconductor Laser Treatment Equipment |
Sinovation (Beijing) Medical Technology Co., Ltd. |
2023/4/4 |
Beijing |
GXZZ 20233010449 |
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6 |
Coronary Artery CT Fractional Flow Reserve Calculation Software |
Shanghai Pulse Medical Technology Co., Ltd. |
2023/4/4 |
Shanghai |
GXZZ 20233210450 |
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7 |
Single-use Laser Fiber Kit |
Sinovation (Beijing) Medical Technology Co., Ltd. |
2023/4/13 |
Beijing |
GXZZ 20233010485 |
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8 |
Artificial Lens |
Alcon Laboratories, Incorporated |
2023/4/17 |
USA |
GXZJ 20233160146 |
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9 |
Coronary Function Measurement System |
Suzhou RainMed Medical Technology Co., Ltd. |
2023/4/20 |
Suzhou |
GXZZ 20233070520 |
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10 |
Metal Additive Manufacturing Thoracolumbar Fusion Matching Prosthesis System |
Beijing AK Medical Co., Ltd. |
2023/4/21 |
Beijing |
GXZZ 20233130524 |
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11 |
Self-expanding Radioactive Seed-Carried Biliary Stent |
Rongsheng (Nanjing) Medical Technology Co., Ltd. |
2023/5/11 |
Jiangsu |
GXZZ 20233130621 |
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12 |
Computer Aided Detection Software for Intestinal Polyps in Lower Gastrointestinal Endoscopy |
Wuhan ENDOANGEL Medical Technology Co., Ltd. |
2023/5/12 |
Hubei |
GXZZ 20233210629 |
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13 |
Intravascular Imaging Equipment |
Conavi Medical Inc. |
2023/5/16 |
Canada |
GXZJ 20233060200 |
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14 |
Radiation Treatment Planning Software |
Shanghai United Imaging Healthcare Co., Ltd. |
2023/5/23 |
Shanghai |
GXZZ 20233210665 |
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15 |
Computer Aided Detection Software for Electronic Endoscope for Colon Polyps |
Tencent Healthcare (Shenzhen) Co., Ltd. |
2023/6/1 |
Guangdong |
GXZZ 20233210707 |
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16 |
CorPath GRX System Accessories |
Corindus Inc. |
2023/6/1 |
USA |
GXZJ 20233010226 |
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17 |
CorPath GRX System |
Corindus Inc. |
2023/6/1 |
USA |
GXZJ 20233010225 |
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18 |
Carbon Ion Therapy System |
Lanzhou Ion Therapy Co., Ltd. |
2023/6/2 |
Gansu |
GXZZ 20233050708 |
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19 |
Implantable Left Ventricular Assist System |
Shenzhen Core Medical Technology Co., Ltd. |
2023/6/5 |
Guangdong |
GXZZ 20233120716 |
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20 |
Multimodal Tumor Treatment System |
Shanghai Magic Medical Technology Co., Ltd. |
2023/6/8 |
Shanghai |
GXZZ 20233010773 |
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21 |
Implantable Sacral Nerve Stimulator |
Hangzhou Chengnuo Medical Technology Ltd. |
2023/6/14 |
Zhejiang |
GXZZ 20233120807 |
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22 |
Implantable Sacral Nerve Stimulation Extension Wire |
Hangzhou Chengnuo Medical Technology Ltd. |
2023/6/14 |
Zhejiang |
GXZZ 20233120808 |
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23 |
Implantable Sacral Nerve Stimulation Electrode |
Hangzhou Chengnuo Medical Technology Ltd. |
2023/6/14 |
Zhejiang |
GXZZ 20233120809 |
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24 |
Puncture Surgical Navigation Positioning System |
True Health (Beijing) Medical Technology Co., Ltd. |
2023/6/15 |
Beijing |
GXZZ 20233010810 |
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25 |
Zirconium Niobium Alloy Femoral Head |
Suzhou MicroPort Orthopedics Medical Technology Co., Ltd. |
2023/6/15 |
Jiangsu |
GXZZ 20233130813 |
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26 |
Shock Wave Therapy Device |
Shenzhen Wikkon Precision Instruments Co., Ltd. |
2023/6/20 |
Guangdong |
GXZZ 20233090834 |
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27 |
Laparoscopic Single-site Surgery System |
Beijing Surgerii Robotics Company Limited |
2023/6/20 |
Beijing |
GXZZ 20233010833 |
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28 |
ZAP-X Radiosurgery System |
ZAP Surgical Systems, Inc. |
2023/6/20 |
USA |
GXZJ 20233050263 |
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29 |
Knee Replacement Surgery Navigation and Positioning System |
Beijing Tinavi Medical Technologies Co., Ltd. |
2023/7/13 |
Beijing |
GXZZ 20233010962 |
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30 |
Artificial Lens |
Alcon Laboratories, Incorporated |
2023/7/20 |
USA |
GXZJ 20233160317 |
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31 |
Venous Stent System |
Suzhou Innomed Medical Device Co., Ltd. |
2023/7/28 |
Jiangsu |
GXZZ 20233131034 |
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32 |
Medical Electron Linear Accelerator |
OUR United Corp. |
2023/8/1 |
Shaanxi |
GXZZ 20233051067 |
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33 |
Novasight Hybrid Catheter |
Conavi Medical Inc. |
2023/8/1 |
Canada |
GXZJ 20233060333 |
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34 |
Rigid Scleral Contact Lens |
Shanghai Aikangte Medical Technology Co., Ltd. |
2023/8/3 |
Shanghai |
GXZZ 20233161081 |
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35 |
Hip Replacement Surgery Navigation and Positioning System |
Hangzhou Lancet Robotics Company Ltd. |
2023/8/10 |
Zhejiang |
GXZZ 20233011155 |
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36 |
Magnetic Resonance Imaging System |
Wuhan Verlmagin Medical Technology Co., Ltd. |
2023/8/16 |
Hubei |
GXZZ 20233061160 |
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37 |
Intracranial Thrombectomy Stent |
Rapid Medical Ltd. |
2023/8/17 |
Israel |
GXZJ 20233030369 |
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38 |
Balloon Type Cryoablation Catheter |
Shanghai MicroPort EP MedTech Co., Ltd. |
2023/8/23 |
Shanghai |
GXZZ 20233011225 |
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39 |
Cryoablation Device |
Shanghai MicroPort EP MedTech Co., Ltd. |
2023/8/23 |
Shanghai |
GXZZ 20233011226 |
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40 |
Recombinant Humanized Type III Collagen Solution for Injection |
Shanxi Jinbo Bio-pharmaceutical Co., Ltd. |
2023/8/25 |
Shanxi |
GXZZ 20233131245 |
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|
41 |
Mitral Clip System |
Shanghai Hanyu Medical Technology Co., Ltd. |
2023/9/7 |
Shanghai |
GXZZ 20233131292 |
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42 |
Non-small Cell Lung Cancer Tissue TMB Test Kit (Sequencing By Reversible Termination) |
Nanjing Shihe Medical Device Co., Ltd. |
2023/10/12 |
Jiangsu |
GXZZ 20233401452 |
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43 |
X-ray Equipment for Computed Tomography |
Siemens Healthcare GmbH Siemens Healthcare GmbH |
2023/10/16 |
|
GXZJ 20233060455 |
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44 |
Joint Replacement Surgery Simulation Software |
Beijing Longwood Valley MedTech Co., Ltd. |
2023/10/23 |
Beijing |
GXZZ 20233211543 |
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|
45 |
Proton Therapy System |
Varian Medical Systems Particle Therapy GmbH & Co. KG |
2023/11/1 |
Germany |
GXZJ 20233050480 |
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|
46 |
Single-Photon Emission Computed Tomography |
Beijing Novel Medical Equipment Co., Ltd. |
2023/11/7 |
Beijing |
GXZZ 20233061628 |
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|
47 |
Additively Manufactured PEEK Cranial Defect Repair Prosthesis |
Xi'an Kontour Medical Technology Co., Ltd. |
2023/11/9 |
Shaanxi |
GXZZ 20233131652 |
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48 |
Additively Manufactured Matched Artificial Knee Joint Prosthesis |
Naton Biotechnology (Beijing) Co., Ltd. |
2023/11/17 |
Beijing |
GXZZ 20233131698 |
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|
49 |
Laparoscopic Single-site Surgery System |
Shenzhen Edge Medical Technology Co., Ltd. |
2023/11/24 |
Guangdong |
GXZZ 20233011753 |
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50 |
Disposable Intracardiac Ultrasound Diagnostic Catheter |
Jiangsu Tingsn Technology Co., Ltd. |
2023/11/28 |
Jiangsu |
GXZZ 20233061761 |
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51 |
Gelatin-polyethylene Lactone Layered Gum Repair Membrane |
AMOR (Suzhou) Medical Technology Co., Ltd. |
2023/11/29 |
Jiangsu |
GXZZ 20233171776 |
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52 |
Transcatheter Mitral Clip System |
Hangzhou Valgen Medical Technology Co., Ltd. |
2023/11/29 |
Zhejiang |
GXZZ 20233131775 |
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|
53 |
Cryoablation Device |
Cryofocus Medtech (Shanghai) Co., Ltd. |
2023/12/4 |
Shanghai |
GXZZ 20233011815 |
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54 |
Balloon Type Cryoablation Catheter |
Cryofocus Medtech (Shanghai) Co., Ltd. |
2023/12/4 |
Shanghai |
GXZZ 20233011816 |
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55 |
Pelvic fracture reduction surgery navigation and positioning system |
Beijing Rossum Robot Technology Co., Ltd. |
2023/12/8 |
Beijing |
GXZZ 20233011923 |
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|
56 |
Biodegradable Magnesium Closing Clip |
Suzhou Origin Medical Technology Co., Ltd. |
2023/12/13 |
Jiangsu |
GXZZ 20233021931 |
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As of December 12, 2023, 56 innovative medical devices have been approved. |
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