5 unqualified product exposures of medical device quality sampling in Shaanxi Province

in order to ensure the safety of the use of medical devices, our province last year in the provincea total of 556 batches ofmedical device products, the pass rate of 99.1%Yesterday, the provincial Food and Drug Administration publicly exposed supervisionsamplingin the five kinds of non-conforming medical devicesLast year, the province sampling a total of 556 batches of medical device products, testing items in line with the standard provisions of the product 551 batches, the sampling does not meet the standard provisions of the products and related units, the relevant city (district) food and drug supervision and administration department is being investigated and dealt withThese 5 kinds of unqualified products are: Shenzhen Good Life Electronic Technology Co., Ltdproduced a good brand model hyS-1008 low-frequency electronic pulse treatment instrumentThe main problem of non-conformity is that GB9706.1-2007 equipment or equipment components of the external marking, light color, input power and YY0607-2007 output instructions, comprehensive determination does not meet the standard provisions of Guilin latex factory production of The Durex brand 52mm natural latex rubber condom (production batch number G31975023), tested blast volume and pressure (untreated aging condoms) do not meet the standardsThis product has been verified to be produced by a non-labeled production enterpriseHangzhou Hua'an Health Care Supplies Co, Ltdproduction of Antwein brand hard-head electronic thermometer, after testing equipment or equipment parts of the external marking does not meet the standard requirements, after verification, this product for non-labeled production enterprisesChina Suzhou Medical Supplies Factory Co, Ltd production of Huayu brand SDZ-II type electronic needle treatment instrument, the production batch number is 201305, after testing input power does not meet the standard requirements Guangzhou Jianao Technology Co , Ltd production of Antwein brand electronic thermometer, after testing equipment or equipment parts of the external marking does not meet the standard requirements ,