Medical masks have three kinds of, belonging to the second class of medical devices, there is a corresponding implementation of the standard, you need to go to the local provincial Drug Administration to apply for a medical device registration certificate, to get the medical device registration certificate, the company also has to have a The corresponding clean room, through the medical device quality system assessment, get the production license, before you can produce masks in accordance with the corresponding standards.
According to the requirements of the protection standards and applicable scenarios, from high to low is divided into:
1. Medical protective masks: higher level of protection of medical protective masks, is in the isolation ward, isolation of intensive care, fever outpatient special areas, worn by health care workers. Implementing standard GB19083-2010
2. Medical surgical masks: blood and fluid resistant, mainly worn by healthcare workers in invasive operations (body fluids, blood splashes) environment; implementing standard YY0469-2011
3. General medical masks: disposable medical masks, the structure of the rectangle, mainly used in the general diagnostic and treatment environment or low population density scenarios; in line with the relevant registered product standards (YZB) or standard YY/T 0969-2013 "disposable medical masks" related requirements.
To answer the question, there is an accurate medical device registration number and it is not invalid, so it is a medical device. You can go to the State Drug Administration website and enter the registration number to check whether it is real and whether it is within the validity period, you can judge whether it is a real medical device. /datasearchcnda/face3/base.jsp?tableId=26&tableName=TABLE26&title=%B9%FA%B2%FA%D2%BD%C1%C6%C6%F7%D0%B5%B2%FA%C6%B7%A3%A8% D7%A2%B2%E1%A3%A9&bcId=152904417281669781044048234789
Mask registration, based on the national standards for the formulation of their own products, technical requirements, which is also a part of the registration data to be submitted to the Provincial Food and Drug Administration for review, so as long as it is a medical mask, there is certainly the implementation of the standards and technical requirements. standards, there are also technical requirements.