Seven medical devices have been specially approved by the General Administration

Medical Network November 27 hearing recently, the State Food and Drug Administration Medical Devices Technical Review Center announced the public, there are 7 innovative medical devices about to enter the special approval channel. Including:
1. Product Name: Endoscopic optical coherence tomography system
Applicant: Nanjing Minimally Invasive Medical Technology Co., Ltd.
2. Product Name: Abdominal aortic stent graft system
Assignees: Lombard Medical, Ltd.
3. Product Name: Intravascular tomography system
Applicant: Nanjing Welfman Medical Technology Co., Ltd.
4. Product Name: Preimplantation Chromosome Aneuploidy Assay Kit (Co-probe Anchored Aggregation Sequencing)
Applicant: Huada Biological Technology (Wuhan) Co., Ltd.
5. Product Name: balloon dilation endovascular stent-graft system
Assignees: W.L.Gore & Associates, Inc.
6. Product Name: Nerve sleeve
Applicant: Beijing Hui Fukang Medical Technology Co., Ltd.
7. Product Name: Multi-pole synchronized pulmonary artery radiofrequency ablation catheter
Applicant: Wuxi Papu Medical Technology Co., Ltd.
As of now, except the above three medical instruments In addition to the products, CFDA also approved a total of 57 medical device products entering the special approval application channel in the first half of this year. The list is as follows:
1, transcatheter aortic valve system
Applicant: Pegasus Medical Technology (Suzhou) Co., Ltd.
2, bioabsorbable coronary rapamycin stent system
Applicant: Shanghai Bai Xinan Biotechnology Co., Ltd.
3, interventional surgery in the magnetic resonance system
Applicant: Shanghai Ai Lifeng Medical Technology Co., Ltd.
4, low-energy pulse ultrasonic therapy instrument
Applicant: Beijing Wan Bi Li Medical Devices Co., Ltd.
5, SPACO OMX6i medical electron linear accelerator
Applicant: Guangdong Zhongneng Accelerator Technology Co., Ltd.
6, cryogenic surgical system (including disposable sterile cryogenic ablation needle)
Applicant: Hai Geya (Beijing) Medical Devices Co., Ltd.
7, skin photoacoustic microscopy
Applicant: Guangzhou Bai Outing Electronic Technology Co., Ltd.
8, peripheral vascular stent system
Applicant: Suzhou Yinluo Medical Devices Co., Ltd.
Cryofocus cryoablation system (including cryoablation equipment, cryoablation catheter)
Applicant: Health Care Biotech (Shanghai) Co., Ltd.
10, shock wave therapy device
Applicant: Shenzhen Hui Kang Precision Instrument Co., Ltd.
11, left atrial appendage occluder system
Applicant: Hangzhou Nuomo Medical Technology Co., Ltd.
12, drug-eluting peripheral vascular stent system
Applicant: Zhejiang Guichuang Medical Devices Co., Ltd.
13, hydrogen and oxygen atomizer
Applicant: Shanghai Gome Medical Technology Co., Ltd.
14, human SDC2 gene methylation detection kit (fluorescence PCR method)
Applicant: Guangzhou Kang Liming biotechnology limited liability company
15, neurosurgery robot navigation and positioning system
Applicant: Huake Precision (Beijing) Medical Technology Co., Ltd.
16, GNAS gene mutation detection kit
Applicant: Tianjin Jing Naite Gene Biotechnology Co., Ltd.
17, human EGFR gene mutation detection kit (multiplex fluorescence PCR method)
Applicant: Xiamen Aide Biomedical Science and Technology Co., Ltd.
18, human cancer multi-gene mutation detection kit (reversible terminal termination sequencing)
Applicant: Xiamen Aide Biomedical Science and Technology Co., Ltd.
19, paclitaxel elution PTCA balloon dilatation catheter
Applicant: Zhejiang Batai Medical Technology Co., Ltd.
20, abdominal aortic stent graft and delivery system
Applicant: Micro-invasive Heart Vein Medical Technology (Shanghai) Co., Ltd.
21, renal artery radiofrequency catheter ablation
Applicant: Shanghai Micro-invasive Electrophysiology Medical Technology Co., Ltd.
22, collagen cartilage regeneration vector
Applicant: Ubiosis Co.Ltd
23, lung cancer targeted drug gene mutation detection kit (high throughput sequencing)
Applicant: Nanjing World and Medical Devices Co., Ltd.
24, chip digital polymerase chain reaction (DPCR) analysis system
Applicant: Nanjing Ke Weisi Biological Technology Co., Ltd.
25, left atrial appendage occluder
Applicant: Shanghai Shape Memory Alloy Co., Ltd.
26, biochemical immune quantitative analysis system
Assignee: BASEBIOTICS TECHNOLOGY CO., LTD
27, sterile ear clip and delivery system
Applicant: Beijing Meidi Peak Medical Technology Co., Ltd.
28, human EGFR, KRAS, BRAF, PIK3CA, ALK, ROS1 gene mutation detection kit (semiconductor sequencing)
Applicant: Tianjin Nuo Zhiyuan Biological Information Technology Co., Ltd.
19, gastric cancer methylation gene test kit (PCR fluorescence probe method)
Applicant: Born (Beijing) Technology Co., Ltd.
30, neonatal total galactose assay kit (fluorescence analysis)
Applicant: Guangzhou Fenghua Biological Engineering Co., Ltd.
31, product name: low temperature plasma surgical system
Applicant: Beijing North Tesi Technology Co., Ltd.
32, quantitative blood flow fraction measurement system
Applicant: BoMed Medical Imaging Technology (Shanghai) Co., Ltd.
33, adsorption hemodialysis system
Applicant: Medtronic Medical Devices (Chengdu) Co., Ltd.
34, positron emission tomography and magnetic resonance imaging system
Applicant: Shanghai Liangying Medical Technology Co., Ltd.
35, bioabsorbable coronary rapamycin-eluting stent system
Applicant: Beijing Amat Medical Devices Co., Ltd.
36, bioabsorbable coronary rapamycin-eluting stent system
Applicant: Shenzhen Xin Li Tai biomedical Engineering Company Limited
37, near infrared fluorescence imaging system
Applicant: Beijing Digital Precision Medical Technology Co., Ltd.
38, preimplantation chromosome aneuploidy detection kit (semiconductor sequencing method)
Applicant: Chek Hong Medical Technology (Suzhou) Co., Ltd.
39, surgical seal
Applicant: Hangzhou Asia Hui Biotechnology Co., Ltd.
40, IQQA-Guide three-dimensional video navigation system
Applicant: Medstar Medical Technology (Suzhou) Co., Ltd.
41, urinary lithotomy perfusion to attract intelligent control system Qingshi
Applicant: Jiangxi Medical Technology Co., Ltd.
42, renal artery sympathetic multi-polar radiofrequency ablation catheter system
Assignees: Medtronic, Inc.
43, take the stent
Applicant: Zhuhai Tongqiao Medical Technology Co., Ltd.
44. An implanted neurostimulatory system for anti-relapsing treatment in opiate addicts
Applicant: Suzhou King Yu Medical Devices Co., Ltd.
45, bioabsorbable coronary rapamycin-eluting stent system
Applicant: Shanghai Veins Medical Equipment Co., Ltd.
46, left atrial appendage occluder system
Applicant: Shanghai Pushi Medical Devices Technology Co., Ltd.
47, iliac artery bifurcation stent system
Applicant: First Health Technology (Shenzhen) Co., Ltd.
48, Product Name: Straight tube thoracic stent graft system
Applicant: Micro-invasive Heart Vein Medical Technology (Shanghai) Co., Ltd.
49, Product Name: Implanted retinal electrical stimulator
Applicant: Shenzhen Silicon Bionic Technology Co., Ltd.
50, Product Name: Cardiovascular Optical Coherence Imaging System
Applicant: Shenzhen Branch of Micron Medical Devices Technology Co., Ltd.
51, product name: disposable video endoscope catheter
Applicant: Beijing North Tenda Technology Development Co., Ltd.
52, Product Name: Endoscopic surgical equipment control system
Applicant: Shandong Weigao Surgical Robot Co., Ltd.
53, product name: human Tumor Multi-gene mutation detection kit (semiconductor sequencing)
Applicant: Xiamen Flying Shuo Biological Technology Co., Ltd.
54, Product Name: Ventricular Assist System - Implantable Axial Blood Pump
Applicant: Changzhi City Jiu An Artificial Heart Technology Development Co., Ltd.
55, product name: noninvasive blood glucose meter
Applicant: Beijing Sanlian Yonghui Medical Technology Co., Ltd.
56, Product Name: Pressure-Sensitive Magnetic Positioning Radiofrequency Ablation Catheter
Applicant: Shanghai Micro-invasive Electrophysiology Medical Technology Co., Ltd.
57, Product Name: Collagen cartilage regeneration carrier
Applicant: Kang Knee Biomedical (Shenzhen) Co., Ltd.
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