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| The examination results of special examination and approval of innovative medical devices will be published |
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| Author：中国铭铉 企划部 Release Time：2017-9-15 10:31:23 Number Browse：947 |
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Medical network - on September 15, according to the state food and drug supervision and management of the administration of the innovative medical devices for examination and approval of special program (try out) "(drug safety food machinery tube [2014] no. 13) requirement, innovation medical instrument examination office organization experts on medical equipment special request for approval to the examination, to agree to the following application project into the special examination and approval procedures, now be published.
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
Public time: September 13, 2017 solstice, September 26, 2017
During the period of public notice, any unit or individual may have any objection, which may be reflected in the comprehensive business of my center by means of written, telephone or email.
Lian: xu liang
Telephone: 010-86452911
Email: xuliang@cmde.org.cn
Address: room 202, no. 55, xiwai village, haidian district, Beijing
The state administration of food and drug administration
Medical device technical evaluation center
September 13, 2017
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