Release date: 2018-07-19
Announcement of the results of the examination of the application for the examination of the special medical equipment (No. 8 of 2018)
According to the requirements of the State Food and Drug Administration's "Special Approval Procedure for Innovative Medical Devices (Trial)" (Food and Drug Administration [2014] No. 13), the Innovative Medical Device Review Office organized relevant experts to review the application for special approval for innovative medical devices. It is proposed to agree to the following application items to enter the special approval process, which is now publicized.
1. Product Name: Branch type intraoperative stent system
Applicant: Wei Chuang Xinmai Medical Technology (Shanghai) Co., Ltd.
2. Product Name: Hepatitis B Virus Surface Antigen (HBsAg) Detection Kit (Chemiluminescence Method)
Applicant: Fujirui Biu Co., Ltd.
3. Product Name: Bio-repair patch
Applicant: Zhuo Hao Medical Technology (Suzhou) Co., Ltd.
Publicity time: July 18, 2018 to July 31, 2018
During the publicity period, if any unit or individual has any objection, it may report it to the General Business Department of our center in writing, by telephone or by mail.
Contact: Lan Lan
phone
E-mail:
Address: Room 202, Building 1, No. 50, Meteorological Road, Beijing
Source: CMDE
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