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| In 2017, a total of 54 medical devices will be put into special examination and approval |
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| Author：中國銘鉉 企劃部 Release Time：2017-9-18 11:21:46 Number Browse：1404 |
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On September 13, September 13, the state administration of food and drug administration issued a public notice on the medical device technology review center, and 7 innovative medical devices will soon enter the special examination and approval channels.
1. Product name: direct tube thoracic aortic laminating stent system
Application: minimally invasive pulse medical technology (Shanghai) co. LTD
2. Product name: implantable retinal electric stimulator
Shen: shenzhen silicon-based bionic technology co. LTD
3. Product name: cardiovascular optical coherent imaging system
Shen: shenzhen zhongke microlight medical device technology co. LTD
4. Product name: disposable visual endoscopic catheter
Shen invited: Beijing north tengda technology development co. LTD
5. Product name: endoscopic surgical instrument control system
Shen: shandong weigao surgery robot co. LTD
6. Product name: human tumor multi-gene mutation detection kit (semiconductor sequencing)
Shen: xiamen feishuo biotechnology co. LTD
7. Product name: ventricular assist system - implantable axial bleeding pump
Shen: changzhi changan artificial heart technology development co. LTD
39 innovative medical devices enter the CFDA special approval channel
As of today, in addition to the above seven medical device products, CFDA approved 47 medical device products in the first half of this year. Include:
1. Through the catheter aortic valve system
Applicant: peijia medical technology (suzhou) co. LTD
2. Bioabsorption of the coronary arterial rapamycin eluting stent system
Applicant: Shanghai baixin biotechnology co. LTD
3. Interventional magnetic resonance system
Applicant: Shanghai airifeng medical technology co. LTD
4. Low energy pulse ultrasonic therapeutic apparatus
Applicant: Beijing wanli force medical equipment co. LTD
5. SPACO OMX6i medical electron linear accelerator
Applicant: guangdong energy accelerator technology co. LTD
6. Cryogenic cryosurgery system (including disposable sterile cryoablation needle)
Applicant: hai jaya (Beijing) medical equipment co. LTD
7. Skin photomicrograph
Applicant: guangzhou baihe electronic technology co. LTD
8. Peripheral vascular stent system
Applicant: suzhou yinluo medical equipment co. LTD
9. Cryofocus cryoablation system (including cryoablation equipment, cryoablation catheter)
Applicant: kangfo biotechnology (Shanghai) co. LTD
10. Shockwave therapeutic apparatus
Applicant: shenzhen huikang precision instrument co. LTD
11. Left atrial closure system
Applicant: hangzhou nuomao medical technology co. LTD
12. Drug eluting peripheral vascular stent system
Applicant: zhejiang guichuang medical equipment co. LTD
13. Hydrogen and oxygen aerosol
Applicant: Shanghai Hui medical technology co., LTD
14. Human SDC2 gene methylation test kit (fluorescent PCR)
Applicant: guangzhou kangli Ming biotechnology co. LTD
15. Neurosurgical robot navigation and positioning system
Applicant: huake precision (Beijing) medical technology co. LTD
16. GNAS gene mutation detection kit
Applicant: tianjin fine resistance gene biotechnology co. LTD
17. Human EGFR gene mutation detection kit (multiple fluorescent PCR)
Applicant: xiamen edade biological medicine technology co. LTD
18. Joint test kit for multi-gene mutation of human cancer (reversible terminal termination sequencing method)
Applicant: xiamen edade biological medicine technology co. LTD
19. Paclitaxel eluting PTCA balloon dilation catheter
Applicant: zhejiang batai medical technology co. LTD
20. Abdominal aortic laminated scaffolds and delivery systems
Applicant: minimally invasive pulse medical technology (Shanghai) co. LTD
21. Renal artery radiofrequency ablation catheter
Applicant: Shanghai micro-chuang electrophysiological 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 method)
Applicant: nanjing world and medical equipment co. LTD
24. Chip digital polymerase chain reaction (DPCR) analysis system
Applicant: nanjing kovitsi biotechnology co. LTD
25, left heart ear closure
Applicant: Shanghai shape memory alloy material co. LTD
26. Biochemical immune quantitative analysis system
Applicant: basic egg biotechnology co. LTD
27. Sterile heart ear clip and conveying system
Applicant: Beijing meidi summit medical technology co. LTD
28. Human EGFR, KRAS, BRAF, PIK3CA, ALK and ROS1 gene mutation detection kit (semiconductor sequencing method)
Applicant: tianjin norhe zhiyuan bio-information technology co. LTD
19. Gastric cancer methylation gene detection kit (PCR fluorescence probe method)
Applicant: bocheng (Beijing) technology co., LTD
30. Neonatal total galactose determination kit (fluorescence analysis)
Applicant: guangzhou fenghua biological engineering co. LTD
31. Product name: low-temperature plasma operating system
Applicant: Beijing nortes technology co. LTD
32. Quantitative blood flow score measurement system
Applicant: bog medical imaging technology (Shanghai) co. LTD
33. Adsorption hemodialysis system
Applicant: medtronic medical instrument (chengdu) co. LTD
Electron emission tomography and magnetic resonance imaging system
Applicant: Shanghai lianying medical technology co. LTD
35. Bioabsorbable coronary arterial rapamycin eluting stent system
Applicant: Beijing amet medical equipment co. LTD
36. Bioabsorption of the coronary arterial rapamycin eluting stent system
Applicant: shenzhen xinlitai biological medical engineering co. LTD
37. Near-infrared fluorescence imaging system
Applicant: Beijing digital precision medical technology co. LTD
38. Pre-implantation of preimplantation chromosome aneuploid test kit (semiconductor sequencing)
Applicant: orderkang medical technology (suzhou) co. LTD
39. Surgical sealant
Applicant: hangzhou yhui biotechnology co. LTD
40. The navigation system of IQQA-Guide 3d imaging
Applicant: medical star medical technology (suzhou) co. LTD
The lithotripsy in the urinary cavity attracts intelligent control of the stone system
Applicant: jiangxi medical technology co. LTD
42. Renal artery sympathetic multipolar radiofrequency ablation catheter system
Applicant: Medtronic, Inc.
43. Pin support
Applicant: zhuhai tongqiao medical technology co. LTD
44. Implantable neural stimulation system for anti-relapse therapy for opioid addicts
Applicant: suzhou jingyu medical equipment co. LTD
45. Bioabsorbable coronary arterial rapamycin eluting stent system
Applicant: Shanghai mai quan medical equipment co. LTD
46. Left atrial closure system
Applicant: Shanghai pushi medical equipment technology co. LTD
47. Iliac artery bifurcation scaffold system
Applicant: first health technology (shenzhen) co. LTD
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