National Food and Drug Administration, sampling electronic thermometers and other three medical devices failed
Recently, the State Food and Drug Administration has organized quality supervision and sampling of products of 247 batches (sets) of three varieties, including disposable tracheal intubation and medical electronic thermometers.
The medical device products that are not in compliance with the standard are required to be sampled, involving 3 varieties and 4 batches (sets) of 4 medical device manufacturers. Specifically:
Medical electronic thermometer 1 company, 1 product. A digital electronic thermometer produced by Dongguan Xiehe Medical Device Technology Co., Ltd., the maximum allowable error does not meet the standard;
One-time use of tracheal intubation in 2 companies of 2 companies. Each batch of tracheal intubation produced by Henan Yadu Industrial Co., Ltd. and Henan Jianqi Medical Devices Co., Ltd., the cuff (filling the diameter) does not meet the standard;
Elastomer impression material 1 company 1 batch of products. One batch of elastomeric impression materials produced by Shandong Huge Dental Materials Co., Ltd. does not meet the standard requirements for working hours.
The sample items to be inspected are medical device products that do not meet the standards as specified in the label, manual, etc., and involve 2 varieties of 2 medical device manufacturers, specifically:
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