CFDA's National Medical Device Quality Bulletin (No. 4, 2016, Issue 12) was released on June 27.
The results are as follows:
One or three medical device manufacturers' 2 varieties (four sets) of products were not tested in accordance with the standards.
1. Two batches of medical disposable protective clothing produced by Henan Jianqi Medical Devices Co., Ltd., the appearance and filtration efficiency do not meet the standard requirements;
2. One batch of medical disposable protective clothing produced by Chongyang Steady Medical Textile Co., Ltd., the appearance and breaking strength do not meet the standard;
3. One BPM series electronic sphygmomanometer produced by Haozhan Medical Technology (Wujiang) Co., Ltd., the color of the button without the light does not meet the standard.
2. The items to be tested are medical device products that do not meet the standards as specified in the label, instruction manual, etc., and involve 20 varieties (sets) of non-invasive automatic blood pressure monitors (electronic blood pressure monitors) of 16 medical device manufacturers.
(1) The 18 batches (sets) of 14 mechanical enterprises have not met the standards.
1. Two digital electronic blood pressure monitors produced by Dong'e Ejiao Ahua Medical Devices Co., Ltd.;
2. Two arm digital electronic blood pressure monitors produced by Shenzhen Jiemeirui Medical Technology Co., Ltd.;
3. Two electronic blood pressure monitors produced by Jiangsu Fulin Medical Equipment Co., Ltd.;
4. Two electronic blood pressure monitors produced by Jiangsu Yuyue Medical Equipment Co., Ltd.;
5. One upper arm type electronic sphygmomanometer produced by Zhanke Electronics (Shenzhen) Co., Ltd.;
6. One upper arm type electronic sphygmomanometer produced by Shenzhen Yongmeng Intelligent Information System Co., Ltd.;
7. One arm type electronic sphygmomanometer produced by Shenzhen Ailikang Medical Electronics Co., Ltd.;
8. One arm type electronic sphygmomanometer produced by Beijing Luyuan Hengtai Medical Equipment Co., Ltd.;
9. A music electronic sphygmomanometer produced by Guangdong Lexin Medical Electronics Co., Ltd.;
10. A pulse wave sphygmomanometer produced by Shenzhen Ruiguang Kangtai Technology Co., Ltd.;
11. An arm-type automatic electronic blood pressure monitor produced by Shenzhen Jiakang Technology Co., Ltd.;
12. An arm-type electronic sphygmomanometer produced by Dongguan Huangjiang Bailu Electronics Factory;
13. One upper arm type automatic electronic blood pressure monitor produced by Shandong Yingpa Biotechnology Co., Ltd.;
14. One BPM series electronic sphygmomanometer produced by Haozhan Medical Technology (Wujiang) Co., Ltd.
(2) A data transmission type electronic sphygmomanometer produced by Jiangsu Zhongxun Digital Electronics Co., Ltd., the external marking of equipment or equipment parts does not meet the standard.
(3) One Jinan electronic sphygmomanometer produced by Shandong Dong'an Jinan Electronics Co., Ltd., the external markings and symbols of equipment or equipment parts do not meet the standard.
3. The 170 batches (sets) of 6 varieties of 95 mechanical enterprises, all of which are in compliance with the standards.
For products that do not meet the standards specified in the sampling test, CFDA requires relevant provincial drug regulatory authorities to urge enterprises to ascertain the reasons as soon as possible, formulate rectification measures and rectify them on schedule, and the relevant disposal situation will be announced to the public before July 30, 2016.
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