22 batches of medical device quality | '不关' | Food and Drug Administration is further investigating

Medical Network October 16 News The Food and Drug Administration announced the medical device quality announcement a few days ago. After sampling and verification, 22 batches of products did not meet the standard requirements, involving custom dentures, medical gauze pieces, specific electromagnetic wave therapy devices, etc.

Among the unqualified products, there are 7 batches of custom dentures, and the production units are related to Xiangyang Hongli Denture Co., Ltd., Anhui Yati Denture Technology Co., Ltd., Fuyang Jingcheng Denture Co., Ltd., Tongling Yajia Denture Manufacturing Co., Ltd. Nanling Xinguan Denture Production Co., Ltd., Hefei Changchun Teng Dental Equipment Co., Ltd. Mainly non-standard items are resistant to rapid cooling, porosity, corrosion resistance.

5 batches of medical gauze pieces failed, involving 3 batches of medical skim gauze pieces produced by Henan Xinda Hongda Material Co., Ltd., Yangzhou Jiayun medical instruments Medical absorbent gauze sheet produced by the company, medical gauze piece produced by Yangzhou Tangrong Medical Products Co., Ltd.

According to the announcement, the unqualified products also involve specific electromagnetic spectrum therapy devices, breast treatment devices, etc.

Non-conformity standard 4. The prescribed medical device products, the food and drug supervision department is further investigating.