Which regulation stipulates that breast milk analyzer is not a medical device

The State Food and Drug Administration on the hot and cold dual-control ablation needle and other 166 products medical device classification defined in the document to make a notice, the document number for the state food and drug supervision of mechanical [2011] 231, the document does not as a medical device management of the product to make provisions, which breast milk analyzers do not belong to the management of the product of the medical device, the details of the document in Article 39, in fact, the breast milk analyzers refer to the principle is to refer to the mid-infrared spectrometry, because the method is inconsistent with the progress of the times has been excluded from the category of medical devices. In fact, the principle of breast milk analyzer here refers to the mid-infrared spectroscopy, because the method is inconsistent with the progress of the times, this breast milk analyzer has been excluded from the category of medical devices. Early breastmilk analyzers are using mid-infrared spectroscopy, the Swiss product is, but with the progress of society, technological innovation, ultrasound technology, mid-infrared spectroscopy into the results of the accuracy of the problem, some countries in Europe gradually do not use this technology, as in the previous mid-infrared spectroscopy technology of the breast detector, the early international recognition for the mammary glands of the census, but the accuracy of its into a technological problem, now the international and domestic breastfeeding analyzers are not used in the field of medical equipment. However, due to the technical accuracy problem, international and domestic medical institutions are now using it less, and are switching to using molybdenum target machines for screening. Swiss products claim to be specialized in breast milk analysis, saying that the technology has been approved by IDF (International Dairy Federation) and AOAC (International Association of Official Analytical Chemists) and the gold standard of the dairy industry, which is a one-sided propaganda, and now you can find on the Internet that the breast milk analyzers in Germany, Italy, the United States and Israel are using the latest ultrasound technology, and this breast milk analyzing method is widely recognized in the international community. The newest and most popular method of analyzing breast milk is widely recognized internationally.