255 Medical Devices Approved in China: Medtronic, Mindray, United Imaging Among Key Players

Nov 22, 2024 18:45 CST Updated 18:45

Medtronic

Medical Device Manufacturer

Source: National Medical Products Administration

On November 21, the official website of the National Medical Products Administration released the "Announcement of the National Medical Products Administration on the Approval and Registration of 255 Medical Device Products (October 2024)."

October 2024,NMPA Approves Registration of 255 Medical Device ProductsAmong them, there are 203 Class III medical device products manufactured in China, 25 imported Class III medical device products, 22 imported Class II medical device products, and 5 medical device products from Hong Kong, Macao, and Taiwan.

The approved products includeMedtronic's spinal surgery navigation and positioning system, Mindray's anesthesia system, United Imaging's X-ray computed tomography equipment, Quantun's X-ray computed tomography equipment, Lifescan's non-invasive blood glucose meter, Chunli Zhengda's vertebral fusion device, Dabo's 3D-printed artificial vertebraetc.。

Catalog of Medical Device Products Approved for Registration in October 2024

Serial Number	Product Name	Registrant Name	Registration Certificate Number
Domestic Class III Medical Devices
1	Radiofrequency Skin Treatment Device	Shenzhen Zongjiang Technology Co., Ltd.	CN Medical Device Registration Approval 20243092006
2	Free Prostate-Specific Antigen Calibrator	Jiangsu Sanlian Bioengineering Co., Ltd.	CN Medical Device Registration No. 20243402007
3	Anesthesia System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	CN Medical Device Registration No. 20243082008
4	Argon High-Frequency Surgical Device	Beijing Guanbang Technology Group Co., Ltd.	CN Medical Device Registration Approval 20243012009
5	Total Prostate-Specific Antigen (tPSA） Assay Kit (Chemiluminescence Method)	Shenyang Yilu Biotechnology Co., Ltd.	CN Medical Device Registration No. 20243402010
6	14High-Risk Human Papillomavirus Nucleic Acid Typing Detection Kit (Hybrid Capture-Chemiluminescence Method)	Hangzhou Detong Biotechnology Co., Ltd.	CN Medical Device Registration Approval 20243402011
7	Coronary Angiography Image Blood Flow Reserve Fraction Measurement System	Lepu (Beijing) Medical Equipment Co., Ltd.	CN Medical Device Registration No. 20243072012
8	Automated External Defibrillator	Nanjing Shupusida Medical Equipment Co., Ltd.	CN Medical Device Registration No. 20243082013
9	Disposable Ultrasonic Soft Tissue Surgical Blade	Houkai (Tianjin) Medical Technology Co., Ltd.	China Medical Device Registration No. 20243012014
10	Disposable Electrosurgical Snare	Jiangsu Keweiqi Medical Technology Co., Ltd.	China Medical Device Registration Certificate 20243012015
11	Ultrasound Diagnostic Equipment for Endoscopes	Shenzhen Imagic Medical Technology Co., Ltd.	CN Medical Device Registration Approval 20243062016
12	X-ray Computed Tomography Equipment	Shanghai United Imaging Healthcare Co., Ltd.	CN Medical Device Registration No. 20243062017
13	Real-time Fluorescence Quantitative PCR Analyzer	Hotgen (Langfang) Biotechnology Co., Ltd.	China Medical Device Registration No. 20243222018
14	X-ray Computed Tomography Equipment	Quantum (Beijing) Medical Equipment Co., Ltd.	CN Medical Device Registration No. 20243062019
15	Non-invasive Blood Glucose Meter	Lepu (Beijing) Medical Device Co., Ltd.	CN Medical Device Registration Approval 20243072020
16	Radiofrequency Skin Therapy Device	Shenzhen Yushi Technology Co., Ltd.	CN Medical Device Registration No. 20243092021
17	Non-deletion Type α-Thalassemia Gene Detection Kit (Fluorescence PCR-Melting Curve Method)	Yaneng Biotechnology (Shenzhen) Co., Ltd.	China Medical Device Registration No. 20243402022
18	Oral Implant Surgery Navigation and Positioning System	Hangzhou Lancet Robot Co., Ltd.	China Medical Device Registration Certificate 20243012023
19	Intravascular Ultrasound Diagnostic Equipment	Shenzhen Minimally Invasive Trace Medical Equipment Co., Ltd.	CN Medical Device Registration Approval 20243062024
20	ENT Surgical Navigation Equipment	Shandong Weigao Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243012025
21	Single-Use Coronary Intravascular Shock Wave Catheter	Jianwei Medical Technology (Wuxi) Co., Ltd.	CN Medical Device Registration No. 20243012026
22	Plasma Surgical Device	Katyusha (Xiamen) Medical Technology Co., Ltd.	China Medical Device Registration No. 20243012027
23	Intravascular Imaging Device	Shenzhen Imagic Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243062028
24	Combined Detection Kit for Novel Coronavirus (2019-nCoV) and Influenza A/B Virus Nucleic Acid (Fluorescence PCR Method)	Guangzhou Wondfo Biotech Co., Ltd.	CN Medical Device Registration No. 20243402029
25	Electromagnetic Extracorporeal Shock Wave Lithotripter	Shenzhen New Element Medical Technology Development Co., Ltd.	CN Medical Device Registration No. 20243012030
26	CYP3A5 Gene Detection Kit (Fluorescence PCR Method)	Beijing Jingzhun Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243402031
27	Long-pulse Nd:YAG Laser Therapy Device	Suzhou Fumeile Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243092032
28	Parainfluenza Virus Types 1, 2, and 3 Nucleic Acid Detection Kit (Fluorescence PCR Method)	Saintfine Biotechnology Co., Ltd.	CN Medical Device Registration No. 20243402033
29	Disposable Intravascular Ultrasound Diagnostic Catheter	Shenzhen Minimally Invasive Trace Medical Equipment Co., Ltd.	CN Medical Device Registration No. 20243062034
30	Human MTHFR (C677T) Gene Polymorphism Detection Kit (Fluorescence PCR Method)	Xiamen Ampli Bioengineering Co., Ltd.	CN Medical Device Registration No. 20243402035
31	Plasma Surgical Device	Sports Medicine Star (Shanghai) Technology Co., Ltd.	CN Medical Device Registration No. 20243012036
32	Vertebral Fusion Cage	Beijing Chunli Zhengda Medical Devices Joint Stock Company	China Medical Device Registration No. 20243132037
33	Sterile Disposable Injection Needle	Hangzhou MeiYiMei Biotechnology Co., Ltd.	CN Medical Device Registration No. 20243142038
34	Disposable Breast Rotational Biopsy Needle	Chongqing Xishan Technology Co., Ltd.	CN Medical Device Registration No. 20243012039
35	Dental Implant System	Baiti (Xiamen) Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243172040
36	Personalized Implant Bridges and Screws	Anrui Medical Technology (Suzhou) Co., Ltd.	CN Medical Device Registration No. 20243172041
37	Absorbable Hemostatic Liquid Gelatin	Shenzhen Huanuo Biotechnology Co., Ltd.	China Medical Device Registration No. 20243142042
38	Single-use with anti-needle stick precision filter Infusion Set	Chongqing Pharmaceutical Group Weixun Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243142043
39	Porous Tantalum Interbody Fusion Device	Shenzhen Dazhou Medical Technology Co., Ltd.	China Medical Device Registration No. 20243132044
40	Continuous Renal Replacement Therapy Circuit	Chengdu Osai Medical Device Co., Ltd.	CN Medical Device Registration No. 20243102045
41	Ultra-High Molecular Weight Polyethylene Suture	Suzhou Jingjie Medical Technology Co., Ltd.	China Medical Device Registration No. 20243132046
42	Absorbable Surgical Sutures	Nanjing Pulimeng Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243022047
43	Absorbable Surgical Sutures	Nanjing Pulimeng Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243022048
44	Tooth Whitening Agent	Haobai (Zhejiang) Medical Device Co., Ltd.	CN Medical Device Registration No. 20243172049
45	Peripheral Cutting Balloon Catheter	Lepu (Beijing) Medical Device Co., Ltd.	CN Medical Device Registration No. 20243032050
46	Single-Use Microcatheter	Jiangsu Puliyouchuang Technology Co., Ltd.	China Medical Device Registration Certificate 20243032051
47	Distal Protector	Beijing Huamai Taik Medical Device Co., Ltd.	China Medical Device Registration No. 20243032052
48	Vitrification Cryoprotectant Solution	Zhejiang Mingyue Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243182053
49	Hydrophilic Coated Guidewire	Chengdu Dexin An Innovative Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243032054
50	Fully Degradable Nasal Sinus Drug Stent System	Jiangsu Qihao Medical Technology Co., Ltd.	China Medical Device Registration Certificate 20243132055
51	Dental Implant Abutment System	Beijing Chunli Zhengda Medical Devices Joint Stock Company	CN Medical Device Registration No. 20243172056
52	Oral Biofilm	Hangzhou Huamai Medical Technology Co., Ltd.	China Medical Device Registration No. 20243172057
53	Personalized Implant Bridges and Screws	Spacemed (Guangzhou) Technology Co., Ltd.	CN Medical Device Registration No. 20243172058
54	Humeral Intramedullary Nail	Changzhou Jianlibangde Medical Device Co., Ltd.	China Medical Device Registration No. 20243132059
55	Disposable Blood Dialysis Catheter Kit	Suzhou Linhua Medical Device Co., Ltd.	CN Medical Device Registration No. 20243102060
56	Spinal Implantable Drug Delivery Device and Accessories	Suzhou Linhua Medical Device Co., Ltd.	China Medical Device Registration Certificate 20243142061
57	Single-Use Endoscopic Injection Needle	Hangzhou Fuyang Jingrui Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243142062
58	Absorbable Ligation Clips	Aesculap (Xiamen) Medical Devices Co., Ltd.	CN Medical Device Registration No. 20243022063
59	Absorbable Closure Clips and Single-Use Continuous Firing Clip Applier	Beijing Tianzhu Changyun Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243022064
60	Hemodialysis Powder	Hainan Langteng Medical Equipment Co., Ltd.	CN Medical Device Registration No. 20243102065
61	Oral Absorbable Wound Material	Shandong Junxiu Biotechnology Co., Ltd.	CN Medical Device Registration No. 20243172066
62	Ultrasound-Guided Nerve Block Anesthesia Puncture Needle	Guangzhou Weili Medical Devices Co., Ltd.	China Medical Device Registration No. 20243082067
63	Disposable Lumbar Disc Puncture Needle	United Innovation YouTai (Qingdao) Medical Technology Co., Ltd.	CN Medical Device Registration Approval 20243142068
64	Single-Use Hemodialysis Tubing Set	Guangdong Zhong'ai Medical Technology Co., Ltd.	China Medical Device Registration No. 20243102069
65	Single-Use Sterile Injection Needle	Shandong Weigao Purui Pharmaceutical Packaging Co., Ltd.	CN Medical Device Registration Approval 20243142070
66	Microcatheter	Hunan Aipute Medical Device Co., Ltd.	CN Medical Device Registration No. 20243032071
67	Disposable Lumbar Cistern Drainage Catheter Set	Shandong Dazheng Medical Device Co., Ltd.	CN Medical Device Registration No. 20243142072
68	Intracranial Thrombectomy Stent	Changzhou Kainite Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243032073
69	Single-Use Microporous Filter Infusion Set	Weihai Jierui Medical Products Co., Ltd.	CN Medical Device Registration No. 20243142074
70	Cardiac Occluder Delivery System	Beijing Huayi Shengjie Technology Co., Ltd.	CN Medical Device Registration No. 20243032075
71	Caval Filter	Shandong Weixin Medical Device Co., Ltd.	CN Medical Device Registration Approval 20243132076
72	Interspinous Fixation System	Dabo Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243132077
73	Positive Pressure Needleless Connector	Suzhou Xinkangdao Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243142078
74	Additively Manufactured Interbody Fusion Device	Shanghai Xinjian Medical Technology Co., Ltd.	China Medical Device Registration No. 20243132079
75	Hydrogen Peroxide Care Solution	Kangshi Kerun (Beijing) Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243162080
76	Oral Repair Membrane	Nuo Yi Mai Er (Suzhou) Medical Technology Co., Ltd.	China Medical Device Registration Certificate 20243172081
77	Intracranial Guiding Catheter	Sichuan Aimaisi Biomedical Technology Joint Stock Company	CN Medical Device Registration No. 20243032082
78	Dialysate Filter	Bain Medical Equipment (Guangzhou) Co., Ltd.	China Medical Device Registration Certificate 20243102083
79	Atrial Septal Measurement Balloon Catheter	Worry-Free Heartbeat Medical Technology (Shenzhen) Co., Ltd.	CN Medical Device Registration No. 20243032084
80	Single-Use Sterile Hemodialysis Catheter Kit	Suzhou Linhua Medical Device Co., Ltd.	CN Medical Device Registration No. 20243102085
81	Flow Diverter Stent	Aikang Medical Devices (Beijing) Co., Ltd.	China Medical Device Registration No. 20243132086
82	Absorbable Nail Repair Fixator	Tianjin Baihe Zhiyuan Medical Technology Co., Ltd.	China Medical Device Registration Certificate 20243132087
83	Ventilator	Jiangsu Yuyue Medical Equipment Co., Ltd.	China Medical Device Registration No. 20243082088
84	Human IDH1 Gene Mutation Detection Kit (Fluorescence PCR Method)	Xiamen Amoy Diagnostics Co., Ltd.	CN Medical Device Registration No. 20243402089
85	Spinal Surgery Navigation and Positioning System	Shanghai Zhuoxin Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243012090
86	EB Virus Early Antigen (EA) IgA Antibody Detection Kit (Chemiluminescence Immunoassay)	Tongxin Biotechnology (Beijing) Co., Ltd.	China Medical Device Registration Certificate No. 20243402091
87	Free Prostate-Specific Antigen (fPSA) Detection Kit (Chemiluminescence Method)	Shanghai 3D Medicines Biomedical Technology Co., Ltd.	China Medical Device Registration No. 20243402092
88	EB Virus Rta Protein IgG Antibody Detection Kit (Chemiluminescence Immunoassay)	Tongxin Biotechnology (Beijing) Co., Ltd.	China Medical Device Registration No. 20243402093
89	Morphine Hair Detection Kit (Fluorescence Immunochromatography)	Hangzhou Laihe Biotechnology Co., Ltd.	CN Medical Device Registration No. 20243402094
90	Dengue Virus Nucleic Acid Detection Kit (Fluorescence PCR Method)	Jiangsu Shuoshi Biotechnology Co., Ltd.	China Medical Device Registration No. 20243402095
91	Ketamine Hair Test Kit (Fluorescence Immunochromatography)	Hangzhou Laihe Biotechnology Co., Ltd.	China Medical Device Registration Certificate 20243402096
92	Total Prostate-Specific Antigen (tPSA) Detection Kit (Chemiluminescence Method)	Shanghai 3D Medicines Biomedical Technology Co., Ltd.	China Medical Device Registration Certificate 20243402097
93	Bordetella Pertussis Nucleic Acid Detection Kit (Isothermal Amplification - Real-Time Fluorescence Method)	Biodiatech (Xiamen) Biotechnology Co., Ltd.	China Medical Device Registration No. 20243402098
94	Fully Automatic Nucleic Acid Amplification Analyzer	Macro-Micro Test (Suzhou) Bioengineering Co., Ltd.	CN Medical Device Registration No. 20243222099
95	Parainfluenza Virus IgM Antibody Detection Kit (Magnetic Particle Chemiluminescence Method)	Zhengzhou Autobio Engineering Co., Ltd.	China Medical Device Registration Certificate 20243402100
96	Influenza A Virus and Influenza B Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probe Method)	Beijing Beller Biological Engineering Co., Ltd.	CN Medical Device Registration Approval 20243402101
97	Methamphetamine Hair Detection Kit (Fluorescence Immunochromatography)	Hangzhou Laihe Biotechnology Co., Ltd.	China Medical Device Registration Certificate 20243402102
98	Hemodialysis Equipment	Qinhuangdao Mailin Medical Equipment Co., Ltd.	CN Medical Device Registration No. 20243102103
99	Respiratory Syncytial Virus IgM Antibody Test Kit (Chemiluminescence Immunoassay)	Shenzhen New Industries Biomedical Engineering Joint Stock Company	CN Medical Device Registration No. 20243402104
100	Depth of Anesthesia Monitor	Shenzhen Meger Bio-Medical Group Co., Ltd.	CN Medical Device Registration No. 20243072105
101	HER2 Antibody Reagent (Immunohistochemistry)	Henan Sainuote Biotechnology Co., Ltd.	CN Medical Device Registration No. 20243402106
102	ABO Blood Group Typing and RhD Blood Group Typing Test Kit (Solid Phase Method)	Hangzhou AllTest Biotech Co., Ltd.	China Medical Device Registration Certificate No. 20243402107
103	Ultrasonic Diagnosis System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	CN Medical Device Registration No. 20243062108
104	Disposable Ultrasonic Soft Tissue Surgical Blade	SinoMicro Medical Technology (Zhejiang) Co., Ltd.	CN Med Approval 20243012109
105	Thrombus Aspiration Negative Pressure Pump	Zhejiang Guichuang Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243032110
106	Picosecond Nd:YAG Laser Treatment Device	Shenzhen Bandao Medical Group Co., Ltd.	CN Medical Device Registration No. 20243092111
107	Medical Electron Linear Accelerator	Shenyang Neusoft Zhirui Radiation Therapy Technology Co., Ltd.	CN Medical Device Registration No. 20243052112
108	Breast X-ray Image Auxiliary Detection Software	Shanghai United Imaging Intelligence Healthcare Technology Co., Ltd.	CN Medical Device Registration Approval 20243212113
109	Blood Component Separator	Beijing Fuyiyuan Biotechnology Co., Ltd.	China Medical Device Registration No. 20243102114
110	Anesthesia System	Shanghai Dräger Medical Equipment Co., Ltd.	CN Medical Device Registration No. 20243082115
111	Disposable Invasive Blood Pressure Sensor	B. Braun Medical (Suzhou) Co., Ltd.	CN Medical Device Registration No. 20243072116
112	Patient Monitor	Shanghai光电Medical Electronics Instruments Co., Ltd.	CN Medical Device Registration No. 20243072117
113	X-ray Computed Tomography Equipment	Quantum (Beijing) Medical Equipment Co., Ltd.	CN Medical Device Registration No. 20243062118
114	Mycobacterium Tuberculosis Complex Nucleic Acid Detection Kit (Fluorescence PCR Method)	Beijing BOE Zhiwei Microbiology Technology Co., Ltd.	China Medical Device Registration No. 20243402119
115	Irregular Antibody Screening Kit (Human Red Blood Cell Method)	Tianjin Dexiang Biotechnology Co., Ltd.	CN Med Device Reg. 20243402120
116	Multi-channel Physiological Recorder	Shanghai Hongtong Industrial Co., Ltd.	China Medical Device Registration No. 20243072121
117	Quality Control Materials for Nucleic Acid Testing of Lower Respiratory Tract Pathogens	Zhengzhou Autobio Engineering Co., Ltd.	CN Medical Device Registration No. 20243402122
118	Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (Fluorescence PCR Method)	Jiangsu Kangwei Century Biotechnology Co., Ltd.	China Medical Device Registration Certificate 20243402123
119	Single Photon Emission and X-ray Computed Tomography Imaging System	Shanghai Guangmai Medical Technology Co., Ltd.	China Medical Device Registration Certificate No. 20243062124
120	Disposable Radiofrequency Ablation Electrode Needle	Spaidan (Sichuan) Medical Device Co., Ltd.	CN Medical Device Registration Approval 20243012125
121	Mobile C-arm X-ray Machine	Suzhou Yimuwanshang Technology Co., Ltd.	CN Medical Device Registration No. 20243062126
122	Composite Steep Pulse Treatment Device	Shanghai Nuosheng Medical Technology Co., Ltd.	China Medical Device Registration No. 20243092127
123	Composite Steep Pulse Treatment Device	Shanghai Nuosheng Medical Technology Co., Ltd.	China Medical Device Registration No. 20243092128
124	Ultrasonic Soft Tissue Surgical Device	Shanghai RuiSu ChuangSheng Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243012129
125	Disposable Ultrasonic Soft Tissue Surgical Blade	SinoMicro Medical Technology (Zhejiang) Co., Ltd.	CN Medical Device Registration No. 20243012130
126	Total Prostate-Specific Antigen (tPSA) Testing Kit (Electrochemiluminescence Method)	Jiangsu Sanlian Bioengineering Co., Ltd.	CN Medical Device Registration No. 20243402131
127	Positron Emission X-ray Computed Tomography Imaging System	Shenyang Zhihe Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243062132
128	Infusion Pump	Shenzhen Micromed Medical Technology Joint Stock Company	China Medical Device Registration No. 20243142133
129	EB Virus BNLF2b Antibody Detection Kit (Magnetic Particle Chemiluminescence Method)	Xiamen Wantai Kerui Biotechnology Co., Ltd.	CN Medical Device Registration Approval 20243402134
130	PD-L1 (JS311) Antibody Reagent (Immunohistochemistry)	Maijie Translational Medicine Research (Suzhou) Co., Ltd.	China Medical Device Registration No. 20243402135
131	Combined FGFR3/TERT Gene Mutations and ONECUT2/VIM Gene Methylation in Humans Detection Kit (PCR Fluorescence Probe Method)	Tianjin Xiangxin Medical Device Co., Ltd.	China Medical Device Registration No. 20243402136
132	Ultrasonic High-Frequency Surgical Integrated Operating Equipment	Enocom Medical Technology (Suzhou) Co., Ltd.	China Medical Device Registration No. 20243012137
133	Total Prostate Specific Antigen Calibrator	Jiangsu Sanlian Bioengineering Co., Ltd.	CN Medical Device Registration No. 20243402138
134	Argon High-Frequency Surgical Equipment	1313 (Shandong) Electric Co., Ltd.	CN Medical Device Registration No. 20243012139
135	Semiconductor Laser Therapy Device	Hubei Yijiantang Technology Co., Ltd.	CN Medical Device Registration No. 20243092140
136	Morphine, Methamphetamine, Ketamine Combined Hair Detection Kit (Fluorescence Immunochromatography)	Hangzhou Laihe Biotechnology Co., Ltd.	China Medical Device Registration No. 20243402141
137	Alpha-Fetoprotein (AFP) Test Kit (Electrochemiluminescence Method)	Jiangsu Sanlian Bioengineering Co., Ltd.	CN Medical Device Registration No. 20243402142
138	Abnormal Prothrombin Measurement Kit (Chemiluminescence Method)	Sichuan Wowen Te Biotechnology Co., Ltd.	CN Medical Device Registration No. 20243402143
139	Plasma Surgical Device	Suzhou Jingjie Medical Technology Co., Ltd.	China Medical Device Registration No. 20243012144
140	Disposable Electrosurgical Snare	Henghui (Weihai) Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243012145
141	Disposable Radiofrequency Ablation Needle	Beijing Changxiang Tianxing Medical Technology Co., Ltd.	China Medical Device Registration Certificate No. 20243012146
142	Toxoplasma IgG Antibody Assay Kit (Chemiluminescence Method)	Shenzhen Yuhuilong Biotechnology Co., Ltd.	China Medical Device Registration No. 20243402147
143	Human SHOX2/PTGER4 Gene Methylation Test Kit (PCR Fluorescence Method)	Anhui Anlong Gene Technology Co., Ltd.	CN Medical Device Registration No. 20243402148
144	Spinal Surgical Navigation and Positioning System	Medtronic (Changzhou) Medical Device Co., Ltd.	China Medical Device Registration No. 20243012149
145	Hepatitis B Virus (HBV) Nucleic Acid Testing Kit (Fluorescence PCR Method)	Beijing BOE Zhiwei Microbiology Technology Co., Ltd.	CN Med Device Reg. 20243402150
146	Knee Joint Prosthesis System	Yaboneci Medical Technology (Suzhou) Co., Ltd.	China Medical Device Registration No. 20243132151
147	Intracranial Aneurysm Embolization Assist Stent	Shanghai Xinwei Medical Technology Co., Ltd.	China Medical Device Registration No. 20243132152
148	Mapping Angiography Catheter	Hunan Aipute Medical Device Co., Ltd.	CN Medical Device Registration No. 20243032153
149	Hip Prosthesis - Femoral Stem	U.S. Medical Technology (Suzhou) Co., Ltd.	CN Medical Device Registration No. 20243132154
150	Metal Straight Non-Locking Bone Plate	Xiamen Jinding Times Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243132155
151	Locking Bone Plate System	Tianjin Jinxingda Industrial Co., Ltd.	CN Medical Device Registration No. 20243132156
152	Light-Cured Self-Etching Adhesive	Wuhan Golden Dental Materials Co., Ltd.	China Medical Device Registration No. 20243172157
153	Hip Joint Prosthesis - Highly Cross-Linked Acetabular Liner	Naton Biotechnology (Beijing) Co., Ltd.	CN Medical Device Registration No. 20243132158
154	Personalized Polyether Ether Ketone Skull Defect Repair Prosthesis	Xi'an Contec Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243132159
155	Disposable Hemodialyzer	Sichuan Weilisheng Medical Technology Co., Ltd.	China Medical Device Registration No. 20243102160
156	Disposable Infusion Extension Tube	Shenzhen Jinchengrui Medical Technology Co., Ltd.	China Medical Device Registration No. 20243142161
157	Dental Implant	Beijing Chunli Zhengda Medical Devices Joint Stock Company	China Medical Device Registration No. 20243172162
158	Hollow Bone Screw	Beijing Chunli Zhengda Medical Devices Joint Stock Company	CN Medical Device Registration No. 20243132163
159	All-Suture Anchors	Changchun Shengbo Ma Biomaterials Co., Ltd.	China Medical Device Registration Certificate 20243132164
160	Meniscus Suture System	Anhui Bekebio Biotechnology Co., Ltd.	CN Medical Device Registration No. 20243132165
161	Artificial Vertebral Body	Beijing Fule Technology Development Co., Ltd.	CN Medical Device Registration No. 20243132166
162	Disposable Breast Rotational Biopsy Needle	Suzhou Lipu Medical Technology Co., Ltd.	China Medical Device Registration Certificate 20243012167
163	Personalized Bridge and Screws	Changzhou Ruitaik Medical Device Co., Ltd.	CN Medical Device Registration No. 20243172168
164	Metal Cable and Bone Pin Internal Fixation System	Changzhou Hengjie Medical Device Co., Ltd.	China Medical Device Registration No. 20243132169
165	Implant System	Sichuan Diyao Technology Co., Ltd.	CN Medical Device Registration Approval 20243172170
166	Platelet-Rich Plasma Preparation Kit	Zhejiang Disai Biotechnology Co., Ltd.	China Medical Device Registration Certificate 20243102171
167	Metal Hollow Bone Screw	Xiamen Jinding Times Medical Technology Co., Ltd.	China Medical Device Registration No. 20243132172
168	Metal Locking Bone Plate	Sichuan Aerta Medical Device Co., Ltd.	CN Medical Device Registration No. 20243132173
169	Craniomaxillofacial Bone Screw	Xiamen Changying Medical Technology Co., Ltd.	China Medical Device Registration No. 20243132174
170	Platelet-Rich Plasma Preparation Kit	Zhejiang Baorman Biotechnology Co., Ltd.	China Medical Device Registration No. 20243102175
171	Non-compliant Peripheral Balloon Dilatation Catheter	Nanjing Youdebang Medical Technology Co., Ltd.	China Medical Device Registration No. 20243032176
172	All-Suture Anchors	Sports Medicine Star (Shanghai) Technology Co., Ltd.	China Medical Device Registration Certificate 20243132177
173	Soft Hydrophilic Contact Lenses	Jiangsu Tianyan Pharmaceutical Technology Co., Ltd.	CN Medical Device Registration No. 20243162178
174	Coronary Artery Balloon Dilation Catheter	Zhejiang Batai Medical Technology Co., Ltd.	China Medical Device Registration No. 20243032179
175	Peripheral Infusion Catheter	Kossel Medical Technology (Suzhou) Co., Ltd.	CN Medical Device Registration No. 20243032180
176	Soft Hydrophilic Contact Lens	Jilin Ruierkang Optical Technology Co., Ltd.	CN Medical Device Registration No. 20243162181
177	Single-Use Extension Tube	Shenzhen Micromed Life Sciences Co., Ltd.	CN Medical Device Registration No. 20243142182
178	Distal Access Catheter	Shenzhen Liankehanwei Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243032183
179	Absorbable Surgical Sutures	Weihai Weigao Fussen Medical Materials Co., Ltd.	China Medical Device Registration No. 20243022184
180	Absorbable Surgical Sutures	Chengdu Taihe Biomaterials Co., Ltd.	CN Medical Device Registration No. 20243022185
181	Neurovascular Microcatheter	Jinan Zhengbang Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243032186
182	Polydioxanone Facial Implant Threads	Puliran (Nanjing) Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243132187
183	Single-Use Sterile Blunt-Tip Injection Needle	Wenzhou Hongmei Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243142188
184	Rigid Contact Lens Multi-Purpose Solution	Zhuhai Xigu Medical Technology Co., Ltd.	China Medical Device Registration No. 20243162189
185	3D-Printed Artificial Vertebra	Dabo Medical Technology Co., Ltd.	China Medical Device Registration No. 20243132190
186	Craniomaxillofacial Bone Plate	Xiamen Changying Medical Technology Co., Ltd.	China Medical Device Registration No. 20243132191
187	Knee Joint Prosthesis	Tianyan Medical Devices Co., Ltd.	CN Medical Device Registration No. 20243132192
188	Healing Abutment	Sichuan Diyao Technology Co., Ltd.	China Medical Device Registration Certificate No. 20243172193
189	Tooth Bleaching Agent	Haobai (Zhejiang) Medical Device Co., Ltd.	CN Medical Device Registration No. 20243172194
190	Straight Non-Locking Bone Plate	Xiamen Changzhun Medical Technology Co., Ltd.	China Medical Device Registration No. 20243132195
191	Transjugular Intrahepatic Puncture System	Suzhou Hengrui Disheng Medical Technology Co., Ltd.	China Medical Device Registration Certificate 20243032196
192	Single-use Non-compliant Coronary Balloon Dilation Catheter	Dongguan Tian Tian Xiang Shang Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243032197
193	Metal Bone Screw	Xiamen Jinding Times Medical Technology Co., Ltd.	China Medical Device Registration No. 20243132198
194	Metal Locking Bone Screw	Xiamen Jinding Times Medical Technology Co., Ltd.	CN Med Device Reg. 20243132199
195	Soft Hydrophilic Contact Lenses	Jiangsu Tianyan Pharmaceutical Technology Co., Ltd.	China Medical Device Registration No. 20243162200
196	Hernia Repair Patch	Shandong Haidike Medical Products Co., Ltd.	China Medical Device Registration Certificate 20243132201
197	Scale Flow Adjustable Light-Shielding Pump for Use Precision Filtration Infusion Set	Jiangsu Yibei Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243142202
198	Metal Suture Anchor with Needle	Changchun Sinbon Biomaterial Co., Ltd.	CN Medical Device Registration No. 20243132203
199	Tantalum-coated Metal Locking Intramedullary Nail	Beijing Huatan Biotechnology Development Co., Ltd.	CN Medical Device Registration No. 20243132204
200	High-Pressure Contrast Injector System Kit	Medtronic (Suzhou) Medical Equipment Co., Ltd.	CN Medical Device Registration No. 20243062205
201	Delivery System	Guangzhou Qijun Biotechnology Co., Ltd.	CN Medical Device Registration No. 20243032206
202	Coronary Artery Balloon Dilation Catheter	Zhejiang Batai Medical Technology Co., Ltd.	CN Medical Device Registration No. 20243032207
203	Single-use Blood Perfusion Device	Weihai Weigao Life Science Technology Co., Ltd.	China Medical Device Registration No. 20243102208
Imported Class III Medical Devices
204	Rechargeable Implantable Deep Brain Stimulator	Boston Scientific Neuromodulation Corporation	CN Medical Device Registration Import 20243120560
205	Implantable Deep Brain Stimulation Electrode	Boston Scientific Neuromodulation Corporation	China Medical Device Registration No. 20243120561
206	Plasma Surgical Device	Apyx Medical Corporation	China Medical Device Registration No. 20243010567
207	Single-use Magnetic and Electrical Localization Pressure Monitoring Radiofrequency Ablation Catheter	Abbott Medical	CN Medical Device Registration Import 20243010568
208	Rh Blood Group Antigen Typing Detection Card (Microcolumn Gel Method)	DiaMed GmbH	CN Medical Device Registration Import 20243400569
209	Rapamycin-Coated Coronary Drug Balloon Dilatation Catheter	B. Braun Melsungen AG	CN Medical Device Registration Import 20243030574
210	Thrombectomy Catheter	Stryker Neurovascular	CN Med Device Reg. No. 20243030575
211	Peripheral Vascular Balloon Dilation Catheter	Genoss Co., Ltd.	CN Medical Device Registration No. 20243030576
212	Disposable Blood Component Separator	Fresenius Kabi AG	CN Med Device Reg 20243100577
213	Dexamethasone Implant Intravitreal Delivery Kit	EyePoint Pharmaceuticals, Inc	CN Medical Device Registration Import 20243160578
214	Cochlear Implant	Advanced Bionics LLC	China Medical Device Registration No. 20243120579
215	Implantable Deep Brain Stimulation Electrode	Boston Scientific Neuromodulation Corporation	China Medical Device Registration No. 20243120580
216	Fetal Chromosome Aneuploidy (T13, T18, T21, X and Y) Test Kit (Fluorescence PCR Capillary Electrophoresis Method)	Devyser AB	CN Med Device Reg Cert 20243400581
217	Cochlear Implant	Advanced Bionics LLC	China Medical Device Registration No. 20243120582
218	Cryolipolysis Device	ZELTIQ Aesthetics, Inc.	CN Med Device Reg. No. 20243010583
219	Single-Use Electric Endoscopic Pre-Embedded Chip Cutting Stapler	Ethicon Endo-Surgery, LLC	CN Medtronic Registration 20243010584
220	Ophthalmic Ultrasound Diagnostic Instrument	QUANTEL MEDICAL	China Medical Device Registration No. 20243160585
221	Magnetic Resonance Imaging System	Siemens Healthcare GmbH	CN Medical Device Registration Import 20243060586
222	Rubella Virus IgM Calibrator	Abbott Ireland Diagnostics Division	CN Medical Device Registration Import 20243400595
223	Hepatitis B Virus Core Antibody Quality Control Products	Siemens Healthcare Diagnostics Products Limited	CN Med Device Reg Cert 20243400596
224	Absorbable Microporous Polysaccharide Hemostatic Powder	PlantTec Medical Gmbh	CN Medical Device Registration Import 20243140602
225	Dry-type Mitral Valve	Edwards Lifesciences LLC	China Medical Device Registration No. 20243130603
226	Soft Hydrophilic Contact Lenses	Alcon Laboratories, Inc.	China Medical Device Registration No. 20243160604
227	Cobalt Chromium Everolimus-Eluting Coronary Stent Stent System	Abbott Medical	CN Medical Device Registration Import 20243130605
228	Multi-Function Contact Lens Solution	OPTO-PHARM PTE LTD	China Medical Device Registration No. 20243160606
Imported Class II Medical Devices
229	Fully Automatic Immunoblotting Instrument	Bee Robotics Ltd.	China Medical Device Registration No. 20242220562
230	Amblyopia Treatment Equipment	NovaSight Ltd.	China Medical Device Registration No. 20242160563
231	Activated Partial Thromboplastin Time (APTT) Quality Control Material	Accriva Diagnostics, Inc.	China Medical Device Registration No. 20242400564
232	External Deep Brain Neurostimulator	Boston Scientific Neuromodulation Corporation	China Medical Device Registration No. 20242120565
233	Sound Processor	MED-EL Elektromedizinische Geräte GmbH	China Medical Device Registration No. 20242120566
234	Endoscope Cleaning and Disinfection Equipment	Olympus Medical Systems Corporation	CN Medical Device Registration Import 20242110570
235	Portable Cryotherapy Device	RecensMedical, Inc.	CN Med Device Reg Cert 20242090571
236	Electric Bone Tissue Surgery Handpiece	Stryker Instruments	China Medical Device Registration No. 20242040572
237	Single-Use Electronic Ureteral Renal Pelvis Endoscope Catheter	KARL STORZ SE & Co. KG	China Medical Device Registration No. 20242060573
238	Cyclooxygenase-1 Pathway Platelet Aggregation Function Test Card (Optical Turbidimetry)	Accriva Diagnostics, Inc.	CN Med Device Reg Cert 20242400587
239	Sleep Recorder	SOMNOmedics GmbH	China Medical Device Registration No. 20242070588
240	Deep Brain Neurostimulation Patient Programmer	Boston Scientific Neuromodulation Corporation	China Medical Device Registration No. 20242120589
241	Disposable Argon Electrode	WEM Equipamentos Eletrônicos Ltda.	CN Medical Device Registration Import 20242010590
242	Finger Cot Sensor	Edwards Lifesciences LLC	China Medical Device Registration No. 20242070591
243	Dental Implant Surgery Planning Software	3Shape A/S	China Medical Device Registration No. 20242210592
244	Medical Image Storage and Transmission Software	Philips Medical Systems Nederland B.V.	CN Medtronic Registration No. 20242210593
245	Medical Image Processing Software	Philips Medical Systems Nederland B.V.	CN Medical Device Registration Import 20242210594
246	Embryo Incubator	COOPERSURGICAL,INC.	CN Medical Device Registration Import 20242180597
247	Disposable Cutting Forceps	Erbe Elektromedizin GmbH	CN Medical Device Registration No. 20242010598
248	Disposable Skin Stapler	SURGINUS Co., Ltd	CN Medical Device Registration Import 20242020599
249	Compression Hemostasis Device for Pouch	Merit Medical Systems, Inc.	China Medical Device Registration No. 20242140600
250	Grinding Head	Medtronic Xomed, Inc.	CN Medical Device Registration Import 20242040601
Medical Devices from Hong Kong, Macao, and Taiwan
251	Soft Hydrophilic Contact Lenses	Eternity Optical Co., Ltd.	CN Medical Device Registration Approval 20243160020
252	Soft Hydrophilic Contact Lenses	BenQ Materials Corporation	CN Medical Device Registration Permit 20243160021
253	Soft Hydrophilic Contact Lenses	Yujia Technology Co., Ltd.	CN Medical Device Registration Permit 20243160024
254	Positive Pressure Ventilation Mask	Jawbone Corporation	CN Medical Device Registration Permit 20242080022
255	Anesthesia Breathing Circuit and Accessories	Taiwan Yanda Co., Ltd.	CN Medical Device Registration Permit 20242080023

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