Liaoning medical device sampling inspection shows that there are more unqualified medical products

The Liaoning Food and Drug Administration recently issued a medical device quality announcement. The results showed that there were more unqualified items in medical electrical products, and 32 sets of medical electrical products were randomly selected and inspected, and some of the 20 (sets) product inspection items did not meet the standard.

The batch production company is a batch of specific electromagnetic wave therapeutic devices produced by Chongqing Zhongzhi Medical Instrument Co., Ltd. The unqualified sample samples are “protective grounding terminals”. The marking manufacturer is a batch of compressed atomizers produced by Ledaoke Electronics Manufacturing (Nantong) Co., Ltd., and the sampling unqualified items are “connection with power source”. Mark the production enterprise as a batch of far-infrared physiotherapy device produced by Cangzhou Hongguang Rehabilitation Equipment Factory. The unqualified samples of sampling samples have “stability during normal use”.

In addition, Liaoning Province medical device sampling test does not meet the standard list of products, the production company is Maoming City Jiangyuan Latex Products Co., Ltd., a batch of natural latex rubber condoms produced, sample unqualified items are "untreated" Condom blast volume and pressure". The production enterprise is a batch of disposable sterile catheterization kits produced by Xinxiang Huakang Weicai Co., Ltd. The sample unqualified samples are “sterile”.

In the production, operation and use of medical devices, the Liaoning Food and Drug Administration has carried out random inspections on 245 batches (sets, sets) of medical device products in 8 categories (species), and has inspected and dealt with products that do not meet the standards.

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