July 7, 2022

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100 Innovative Medical Devices Approved By China Drug Administration

100 Innovative Medical Devices Approved By China Drug Administration


 

100 Innovative Medical Devices Approved By China Drug Administration. Medical devices on the list are China’s first self-developed  for reconstruction of internal iliac artery.  This list attached.

The 100th innovative device was approved

On January 13, according to the State Drug Administration, after review, the application for registration of the innovative product “iliac artery bifurcation stent system” produced by Lifetech (Shenzhen) Co., Ltd. was approved for the treatment of abdominal iliac aneurysms or common iliac artery tumor.

On the same day, the State  Drug Administration released the “State  Drug Administration Holds Innovative Medical Device Achievement Report Video Conference”, showing that since 2014, the State Drug Administration set up a rapid approval channel for innovative medical devices, and a total of 100 innovative medical devices have been approved for listing.

100 Innovative Medical Devices Approved By China Drug Administration

 

These innovative medical devices are close to or reach the international advanced level and have significant clinical application value. Some innovative medical devices fill the gaps in related fields in China, better meet the people’s demand for high-quality and high-level medical devices, and effectively guarantee the promotion of the people. The lives of the people are healthy.

Since 2014, China has actively created a policy atmosphere that encourages innovation and promoted the innovation-driven development track of medical devices.

On February 7, 2014, the former State  Drug Administration issued the “Special Approval Procedure for Innovative Medical Devices (Trial)”, which came into effect on March 1, 2014, which opened up the boom in China’s innovative medical devices prelude.

As of November 2018, the State  Drug Administration revised and issued the “Special Review Procedures for Innovative Medical Devices”, which improved the applicable conditions, refined the application process, improved the effectiveness of innovation review, improved the review method and notification form, and clarified the Priority is given to changes in the licensing of innovative medical devices.

 

Domestic equipment accounted for 96%

According to the China  Drug Network, since the opening of the “green channel” for innovative medical devices in 2014, as of the end of December 2020, 1471 products have applied to enter the innovation channel, and 292 products have been included in the channel as innovative medical devices, accounting for approximately all About 20% of applied projects. Up to now, a total of 100 innovative medical devices have been approved for marketing.

In recent years, the number of innovative medical devices approved has basically increased year by year. 1 innovative device was approved in 2014, 9 in 2015, 11 in 2016, 12 in 2017, 21 in 2018, and approval in 2019 19, 26 approved in 2020.

Among the 100 products, 96 are domestic products, involving 78 medical device companies in 14 provinces, autonomous regions and municipalities directly under the Central Government, accounting for 96% of all products, and 4 are imported products, involving 4 companies in two countries. In terms of approved product locations, major industrial provinces ranked high in the number of innovative medical devices, with 25 in Beijing, 19 in Shanghai, 17 in Guangdong, and 14 in Jiangsu. In terms of product characteristics, there are 43 active devices, 37 passive devices, and 20 in vitro diagnostic reagents and equipment.

Researchers from the School of Medical Devices and Food, University of Shanghai for Science and Technology published an article analysis in “Progress in Biomedical Engineering”. China’s medical device industry is still in the early stage of innovative development. Medical device products have rapid iterations, short R&D cycles and original The characteristics of slower technology update are mainly aimed at improved innovation, and more attention is paid to the commercialization and clinicalization of mature technologies.

In view of China’s current development trend, gradually replacing imports will be the main theme of the industry’s development in the next decade. Looking back on the successful experience in the field of import substitution, China will realize import substitution in more subdivided fields in the future.

Independent innovation, platform-based layout, and extension to the downstream industrial chain are the development logic of China’s equipment companies other than import substitution.

At the same time, Chinahas formed a number of specialized industrial clusters in the supporting industrial chain, creating favorable conditions for cost control and expansion of production scale. Based on the huge consumer groups and the support of relevant departments, the development of China’s medical device market is extremely broad.

From imitation to imitation, and then to creation, China’s medical device industry is constantly upgrading, and the huge space for industry development has become a battleground for medical companies. The continuous maturity of the capital market provides a strong guarantee for the production of medical devices. A good external environment and years of talent accumulation have helped us to start a new wave of medical device innovation in China.

(sourceinternet, reference only)


    

 


Appendix:  Innovative medical devices approved by China Drug Administration

No.ProductManufacturerRegistration number
1Gene sequencerShenzhen Huayinkang Gene Technology Co., Ltd.National Machinery Note 20143402171
2Constant temperature amplification microfluidic chip nucleic acid analyzerBoao Biological Group Co., Ltd.National Machinery Note 20153400580
3Dual-channel implantable deep brain electrical stimulation pulse generator kitSuzhou Jingyu Medical Equipment Co., Ltd.National Machinery Note 20153210970
4Implantable deep brain stimulation electrode lead kitSuzhou Jingyu Medical Equipment Co., Ltd.National Machinery Note 20153210971
5Implantable deep brain stimulation extension lead kitSuzhou Jingyu Medical Equipment Co., Ltd.National Machinery Note 20153210972
6MTHFR C677T gene detection kit (PCR-gold magnetic particle chromatography)Xi’an Gold Magnetic Nano Biotechnology Co., Ltd.National Machinery Note 20153401148
7Acellular corneal stromaShenzhen Ainier Corneal Engineering Co., Ltd.National Machinery Note 20153460581
8Septin9 gene methylation detection kit (PCR fluorescent probe method)Boercheng (Beijing) Technology Co., Ltd.National Machinery Note 20153401481
9Digital tomography equipment for mammography X-rayCorning (Tianjin) Medical Equipment Co., Ltd.National Machinery Note 20153302052
10Survival Motor Neuron Gene 1 (SMN1) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)Shanghai Wise Stone Medical Research Co., Ltd.National Machinery Note 20153402293
11Three-dimensional cardiac electrophysiological mapping systemShanghai MicroPort Electrophysiology Medical Technology Co., Ltd.National Machinery Note 20163770387
12Respiratory tract pathogenic bacteria nucleic acid detection kit (constant temperature amplification chip method)Boao Biological Group Co., Ltd.National Machinery Note 20163400327
13Acellular corneal graftGuangzhou Youdeqing Biological Technology Co., Ltd.National Machinery Note 20163460573
14Implantable vagus nerve stimulation pulse generator kitBeijing Pinchi Medical Equipment Co., Ltd.National Machinery Note 20163210989
15Implantable vagus nerve stimulation electrode lead kitBeijing Pinchi Medical Equipment Co., Ltd.National Machinery Note 20163210990
16Drug-eluting peripheral balloon dilatation catheterBeijing Xianruida Medical Technology Co., Ltd.National Machinery Note 20163771020
17Cold saline perfusion radiofrequency ablation catheterShanghai MicroPort Electrophysiology Medical Technology Co., Ltd.National Machinery Note 20163771040
18Sternum plateChangzhou Huasen Medical Equipment Co., Ltd.National Machinery Note 20163461582
19Positron emission and X-ray computed tomography imaging deviceMingfeng Medical System Co., Ltd.National Machinery Note 20163332156
20Intraocular lensAibo Nord (Beijing) Medical Technology Co., Ltd.National Machinery Note 20163221747
21Orthopedic surgery navigation and positioning systemBeijing Tianzhihang Medical Technology Co., Ltd.National Machinery Note 20163542280
22Cryogenic cryoablation surgery systemHygeia (Beijing) Medical Devices Co., Ltd.National Machinery Note20173583088
23Sterile cryoablation needle for single useHygeia (Beijing) Medical Devices Co., Ltd.National Machinery Note 20173583089
24Variable-angle dual-probe single-photon emission computer tomography equipmentBeijing Yongxin Medical Equipment Co., Ltd.National Machinery Note 20173330681
25Fully degradable sinus drug stent systemPuyi (Shanghai) Biotechnology Co., Ltd.National Machinery Note 20173460679
26Percutaneous interventional artificial heart valve systemHangzhou Qiming Medical Devices Co., Ltd.National Machinery Note 20173460680
27Interventional artificial heart valveSuzhou Jiecheng Medical Technology Co., Ltd.National Machinery Note 20173460698
28Disposable absorbable nail intradermal staplerBeijing Yihe Hengrui Medical Technology Co., Ltd.National Machinery Note 20173650874
29Left atrial appendage occluder systemLifetech Technology (Shenzhen) Co., Ltd.National Machinery Note 20173770881
30Branch type aorta stent graft and delivery systemShanghai MicroPort Medical Equipment (Group) Co., Ltd.National Machinery Note 20173463241
31Foldable artificial vitreous balloonGuangzhou Satellite TV Bo Biological Technology Co., Ltd.National Machinery Note 20173223296
32Abdominal Aorta Stent Graft SystemBeijing Huamai Taike Medical Equipment Co., Ltd.National Machinery Note 20173461434
33Implantable pacemakerLifetech Technology (Shenzhen) Co., Ltd.National Machinery Note 20173211570
34Human EGFR gene mutation detection kit (multiplex fluorescent PCR method)Xiamen Aide Biomedical Technology Co., Ltd.National Machinery Note 20183400014
35Absorbable dural sealing medical glue Shandong Saikesaisi Pharmaceutical Technology Co., Ltd.National Machinery Note 20183650031
36Vascular reconstruction deviceMicroPort Shentong Medical Technology (Shanghai) Co., Ltd.National Machinery Note 20183770102
37miR-92a detection kit (fluorescence RT-PCR method)Shenzhen Jinbaihui Biological Co., Ltd.National Machinery Note 20183400108
38Hepatitis C virus nucleic acid determination kit (PCR-fluorescent probe method)Beijing Najie Diagnostic Reagent Co., Ltd.National Machinery Note 20183400157
39Cerebral thrombus removal deviceJiangsu Nico Medical Equipment Co., Ltd.National Machinery Note 20183770186
40Quantitative blood flow fraction measurement systemBodong Medical Imaging Technology (Shanghai) Co., Ltd.National Machinery Note 20183210282
41Human EGFR/ALK/BRAF/KRAS gene mutation combined detection kit (reversible terminal termination sequencing method)Guangzhou Burning Rock Medical Laboratory Co., Ltd.National Machinery Note 20183400286
42Automatic chemiluminescence immunoassay analyzerBeijing Lianzhong Tech Technology Co., Ltd.National Machinery Note 20183220293
43Human EGFR, KRAS, BRAF, PIK3CA, ALK, ROS1 gene mutation detection kit (semiconductor sequencing method)Tianjin Nuohe Zhiyuan Biological Information Technology Co., Ltd.National Machinery Note20183400294
44Composite hernia repair patchShanghai Songli Biotechnology Co., Ltd.National Machinery Note 20183130292
45Positron emission tomography and magnetic resonance imaging systemShanghai United Imaging Medical Technology Co., Ltd.National Machinery Note20183060337
46EGFR/ALK/ROS1/BRAF/KRAS/HER2 gene mutation detection kit (reversible terminal termination sequencing method)Nanjing Shihe Medical Equipment Co., Ltd.National Machinery Note 20183400408
47Implantable sacral nerve stimulation electrode lead kitBeijing Pinchi Medical Equipment Co., Ltd.National Machinery Note 20183120409
48Implantable sacral nerve stimulator kitBeijing Pinchi Medical Equipment Co., Ltd.National Machinery Note 20183120410
49Human SDC2 Gene Methylation Detection Kit (Fluorescence PCR Method)Guangzhou Kang Liming Biological Technology Co., Ltd.National Machinery Note 20183400506
50Human 10-gene mutation joint detection kit (reversible end termination sequencing method)Xiamen Aide Biomedical Technology Co., Ltd.National Machinery Note 20183400507
51Medical electron linear acceleratorGuangdong Zhongneng Accelerator Technology Co., Ltd.National Machinery Note 20183050520
52Valvuloplasty ringKings Biotechnology (Changshu) Co., Ltd.National Machinery Note 20183130534
53Neurosurgery navigation and positioning systemHuake Precision (Beijing) Medical Technology Co., Ltd.National Machinery Note 20183010598
54Medical linear accelerator systemShanghai United Imaging Medical Technology Co., Ltd.National Machinery Note 20183050599
55Porous tantalum bone filling materialChongqing Runze Pharmaceutical Co., Ltd.National Machinery Note 20193130001
56Bioabsorbable coronary artery rapamycin eluting stent systemLepu (Beijing) Medical Equipment Co., Ltd.National Machinery Note 20193130093
57Patient monitorShenzhen Mindray Biomedical Electronics Co., Ltd.National Machinery Note 20193070154
58Abdominal aorta stent graft and delivery systemMicroPort Cardiovascular Medical Technology (Shanghai) Co., Ltd.National Machinery Note 20193130182
59Left atrial appendage closure systemBeijing Meditop Medical Technology Co., Ltd.National Machinery Note 20193130278
60Left atrial appendage occluder systemShanghai Pushi Medical Equipment Technology Co., Ltd.National Machinery Note 20193130279
61Intensity-modulated radiation therapy planning system softwareZhongke Superfine (Anhui) Technology Co., Ltd.National Machinery Note 20193210281
62Digital mammography systemShanghai United Imaging Medical Technology Co., Ltd.National Machinery Note 20193060280
63Positron emission and X-ray computed tomography scanning systemHubei Ruishi Digital Medical Imaging Technology Co., Ltd.National Machinery Note20193060364
64Micra Transcatheter Leadless Pacemaker systemMedtronicMedtronic Inc.National Machinery Injection 20193120297
65Transcatheter Aortic Valve SystemShanghai MicroPort Xintong Medical Technology Co., Ltd.National Machinery Note 20193130494
66Single-use intravascular imaging catheterNanjing Wolfman Medical Technology Co., Ltd.National Machinery Note 20193060601
67Non-invasive blood glucose meterBobang Fangzhou Medical Technology (Beijing) Co., Ltd.National Machinery Note 20193070602
68Implantable left ventricular assist systemChongqing Yongrenxin Medical Equipment Co., Ltd.National Machinery Note 20193120603
69Acellular corneal graftQingdao Zhonghao Biological Engineering Co., Ltd.National Machinery Note 20193160679
70Coronary angiography blood flow reserve fraction measuring systemSuzhou Runmad Medical Technology Co., Ltd.National Machinery Note 20193070969
71One-time use invasive pressure sensorSuzhou Runmad Medical Technology Co., Ltd.National Machinery Note 20193070970
72Positron emission and X-ray computed tomography scanning systemShanghai United Imaging Medical Technology Co., Ltd.National Machinery Note 20193060998
73Nucleic acid amplification detection analyzerHangzhou Ustar Biotechnology Co., Ltd.National Machinery Note 20193061026
74Puncture surgery navigation equipmentYida Polestar Medical Technology (Suzhou) Co., Ltd.National Machinery Note 20203010034
75Coronary blood flow reserve fraction calculation softwareBeijing Kunlun Medical Cloud Technology Co., Ltd.National Machinery Note 20203210035
76Human EGFR/KRAS/BRAF/HER2/ALK/ROS1 gene mutation detection kit (semiconductor sequencing method)Xiamen Feishuo Biotechnology Co., Ltd.National Machinery Note 20203400094
77Preimplantation chromosome aneuploidy detection kit (semiconductor sequencing method)Suzhou Beikang Medical Devices Co., Ltd.National Machinery Note 20203400181
78Bioabsorbable coronary rapamycin eluting stent systemShandong Huaan Biological Technology Co., Ltd.National Machinery Note 20203130197
79Drug balloon dilatation catheterShanghai MicroPort Xinmai Medical Technology Co., Ltd.National Machinery Note 20203130445
80Cardiovascular optical coherence tomography equipment and accessoriesShenzhen Zhongke Microlight Medical Equipment Technology Co., Ltd.National Machinery Note 20203060446
81RNF180/Septin9 gene methylation detection kit (PCR fluorescent probe method)Boercheng (Beijing) Technology Co., Ltd.National Machinery Note 20203400447
82Plasma surgery equipmentHunan Jingyi Medical Technology Co., Ltd.National Machinery Note 20203010474
83Tumor electric field treatment instrumentNovoCure Ltd.National Machinery Injection 20203090269
84Transcatheter Aortic Valve SystemEdwards Lifesciences LLCNational Machinery Injection 20203130291
85Transcatheter mitral valve clamp and steerable guiding catheterAbbott VascularNational Machinery Injection 20203130325
86Diabetic retinopathy analysis softwareShanghai Yingtong Medical Technology Co., Ltd.National Machinery Note 20203210686
87Diabetic retinopathy fundus image-aided diagnosis softwareShenzhen Siji Intelligent Technology Co., Ltd.National Machinery Note 20203210687
88Hip Joint Coated Ball HeadZhongao Huicheng Technology Co., Ltd.National Machinery Note 20203130707
89Bolt removal bracketZhuhai Tongqiao Medical Technology Co., Ltd.National Machinery Note 20203030728
90Blood flow reserve fraction measuring deviceShenzhen Beixin Life Technology Co., Ltd.National Machinery Note 20203070774
91Pressure microcatheterShenzhen Beixin Life Technology Co., Ltd.National Machinery Note 20203070775
92Hydrogen and oxygen atomizerShanghai Ruomei Medical Technology Co., Ltd.National Machinery Note 20203080066
93Memory alloy nail foot holderLanzhou Ximai Memory Alloy Co., Ltd.National Machinery Note 20203130823
94Coronary CT angiography image vascular stenosis auxiliary triage softwareYukun (Beijing) Network Technology Co., Ltd.National Machinery Note 20203210844
95KRAS gene mutation and BMP3/NDRG4 gene methylation and fecal occult blood combined detection kit (PCR fluorescent probe method-colloidal gold method)Hangzhou Nuohui Health Technology Co., Ltd.National Machinery Note 20203400845
96Drug-eluting PTA balloon dilatation catheterZhejiang Guichuang Medical Equipment Co., Ltd.National Machinery Note 20203030857
97Peripheral nerve repair graftJiangsu Yitong Biological Technology Co., Ltd.National Machinery Note 20203130898
98CT image-assisted detection software for lung nodulesHangzhou Shenrui Bolian Technology Co., Ltd.National Machinery Note 20203210920
99Vertebral artery rapamycin targeting eluting stent systemMicroPort Shentong Medical Technology (Shanghai) Co., Ltd.National Machinery Note 20203130971
100Iliac artery bifurcation stent systemLifetech Technology (Shenzhen) Co., Ltd.National Machinery Note 20213130022

           国家药监局已批准的创新医疗器械

序号产品名称生产企业注册证号
1基因测序仪深圳华因康基因科技有限公司国械注准20143402171
2恒温扩增微流控芯片核酸分析仪博奥生物集团有限公司国械注准20153400580
3双通道植入式脑深部电刺激脉冲发生器套件苏州景昱医疗器械有限公司国械注准20153210970
4植入式脑深部电刺激电极导线套件苏州景昱医疗器械有限公司国械注准20153210971
5植入式脑深部电刺激延伸导线套件苏州景昱医疗器械有限公司国械注准20153210972
6MTHFR C677T 基因检测试剂盒(PCR-金磁微粒层析法)西安金磁纳米生物技术有限公司国械注准20153401148
7脱细胞角膜基质深圳艾尼尔角膜工程有限公司国械注准20153460581
8Septin9基因甲基化检测试剂盒(PCR荧光探针法)博尔诚(北京)科技有限公司国械注准20153401481
9乳腺X射线数字化体层摄影设备科宁(天津)医疗设备有限公司国械注准20153302052
10运动神经元存活基因1(SMN1)外显子缺失检测试剂盒(荧光定量PCR法)上海五色石医学研究有限公司国械注准20153402293
11三维心脏电生理标测系统上海微创电生理医疗科技有限公司国械注准20163770387
12呼吸道病原菌核酸检测试剂盒(恒温扩增芯片法)博奥生物集团有限公司国械注准20163400327
13脱细胞角膜植片广州优得清生物科技有限公司国械注准20163460573
14植入式迷走神经刺激脉冲发生器套件北京品驰医疗设备有限公司国械注准20163210989
15植入式迷走神经刺激电极导线套件北京品驰医疗设备有限公司国械注准20163210990
16药物洗脱外周球囊扩张导管北京先瑞达医疗科技有限公司国械注准20163771020
17冷盐水灌注射频消融导管上海微创电生理医疗科技有限公司国械注准20163771040
18胸骨板常州华森医疗器械有限公司国械注准20163461582
19正电子发射及X射线计算机断层成像装置明峰医疗系统股份有限公司国械注准20163332156
20人工晶状体爱博诺德(北京)医疗科技有限公司国械注准20163221747
21骨科手术导航定位系统北京天智航医疗科技股份有限公司国械注准20163542280
22低温冷冻消融手术系统海杰亚(北京)医疗器械有限公司国械注准20173583088
23一次性使用无菌冷冻消融针海杰亚(北京)医疗器械有限公司国械注准20173583089
24可变角双探头单光子发射计算机断层成像设备北京永新医疗设备有限公司国械注准20173330681
25全降解鼻窦药物支架系统浦易(上海)生物科技有限公司国械注准20173460679
26经皮介入人工心脏瓣膜系统杭州启明医疗器械有限公司国械注准20173460680
27介入人工生物心脏瓣膜苏州杰成医疗科技有限公司国械注准20173460698
28一次性可吸收钉皮内吻合器北京颐合恒瑞医疗科技有限公司国械注准20173650874
29左心耳封堵器系统先健科技(深圳)有限公司国械注准20173770881
30分支型主动脉覆膜支架及输送系统上海微创医疗器械(集团)有限公司国械注准20173463241
31折叠式人工玻璃体球囊广州卫视博生物科技有限公司国械注准20173223296
32腹主动脉覆膜支架系统北京华脉泰科医疗器械有限公司国械注准20173461434
33植入式心脏起搏器先健科技(深圳)有限公司国械注准20173211570
34人类EGFR基因突变检测试剂盒(多重荧光PCR法)厦门艾德生物医药科技股份有限公司国械注准20183400014
35可吸收硬脑膜封合医用胶 山东赛克赛斯药业科技有限公司国械注准20183650031
36血管重建装置微创神通医疗科技(上海)有限公司国械注准20183770102
37miR-92a检测试剂盒(荧光RT-PCR法)深圳市晋百慧生物有限公司国械注准20183400108
38丙型肝炎病毒核酸测定试剂盒(PCR-荧光探针法)北京纳捷诊断试剂有限公司国械注准20183400157
39脑血栓取出装置江苏尼科医疗器械有限公司国械注准20183770186
40定量血流分数测量系统博动医学影像科技(上海)有限公司国械注准20183210282
41人EGFR/ALK/BRAF/KRAS基因突变联合检测试剂盒(可逆末端终止测序法)广州燃石医学检验所有限公司国械注准20183400286
42全自动化学发光免疫分析仪北京联众泰克科技有限公司国械注准20183220293
43人EGFR、KRAS、BRAF、PIK3CA、ALK、ROS1基因突变检测试剂盒(半导体测序法)天津诺禾致源生物信息科技有限公司国械注准20183400294
44复合疝修补补片上海松力生物技术有限公司国械注准20183130292
45正电子发射断层扫描及磁共振成像系统上海联影医疗科技有限公司国械注准20183060337
46EGFR/ALK/ROS1/BRAF/KRAS/HER2基因突变检测试剂盒(可逆末端终止测序法)南京世和医疗器械有限公司国械注准20183400408
47植入式骶神经刺激电极导线套件北京品驰医疗设备有限公司国械注准20183120409
48植入式骶神经刺激器套件北京品驰医疗设备有限公司国械注准20183120410
49人类SDC2基因甲基化检测试剂盒(荧光PCR法)广州市康立明生物科技有限责任公司国械注准20183400506
50人类10基因突变联合检测试剂盒(可逆末端终止测序法)厦门艾德生物医药科技股份有限公司国械注准20183400507
51医用电子直线加速器广东中能加速器科技有限公司国械注准20183050520
52瓣膜成形环金仕生物科技(常熟)有限公司国械注准20183130534
53神经外科手术导航定位系统华科精准(北京)医疗科技有限公司国械注准20183010598
54医用直线加速器系统上海联影医疗科技有限公司国械注准20183050599
55多孔钽骨填充材料重庆润泽医药有限公司国械注准20193130001
56生物可吸收冠状动脉雷帕霉素洗脱支架系统乐普(北京)医疗器械股份有限公司国械注准20193130093
57病人监护仪深圳迈瑞生物医疗电子股份有限公司国械注准20193070154
58腹主动脉覆膜支架及输送系统微创心脉医疗科技(上海)有限公司国械注准20193130182
59左心耳闭合系统北京迈迪顶峰医疗科技有限公司国械注准20193130278
60左心耳封堵器系统上海普实医疗器械科技有限公司国械注准20193130279
61调强放射治疗计划系统软件中科超精(安徽)科技有限公司国械注准20193210281
62数字乳腺X射线摄影系统上海联影医疗科技有限公司国械注准20193060280
63正电子发射及X射线计算机断层成像扫描系统湖北锐世数字医学影像科技有限公司国械注准20193060364
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69脱细胞角膜植片青岛中皓生物工程有限公司国械注准20193160679
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83肿瘤电场治疗仪NovoCure Ltd.国械注进20203090269
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88髋关节镀膜球头中奥汇成科技股份有限公司国械注准20203130707
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92氢氧气雾化机上海潓美医疗科技有限公司国械注准20203080066
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