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Dear Friends Hope that you are safe when you find this email Now the coronavirus are spreading fast all overall the worlds We have good source and contracted production lines for the below masks:Sterile Medical Mask KN95 FFP2 with CE certification ( Conformity Verification Document from DEKRA TESTING CERTIFICATION ) 3 layer flat type surgical mask with CE certificate from Notice

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In Europe surgical masks must wear a CE-mark and comply with the requirements defined in EN 14683: Medical face masks - Requirements and test methods The standard defines surgical masks as: medical devices covering the mouth nose and chin ensuring a barrier that limits the transition of an infectious agent between the hospital staff and the patient

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CE Marking (CE Mark) is a mandatory requirement for medical devices to market in the Europe Medical Device category includes medical equipments medical softwares medical surgical disposables etc CE Marking (CE Mark) is recognized worldwide as a symbol of quality It consists of CE logo and four digit identification number of the certifying notified body (if applicable)

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A surgical mask also known as a face mask is intended to be worn by health professionals during healthcare procedures It is designed to prevent infections in patients and treating personnel by catching bacteria shed in liquid droplets and aerosols from the wearer's mouth and nose They are not designed to protect the wearer from breathing in airborne bacteria or viruses whose particles are

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FDA Requirements to Ship Face Masks to the USA

US Buyers Seek Surgical Mask Suppliers Here are the Regulatory Requirements for Helping to Meet the Demand March 6 2020 COVID-19 has made its way to the United States and has led to a nationwide shortage of face masks Registrar Corp has received many requests from global manufacturers for assistance with U S Food and Drug Administration (FDA) regulations for exporting

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Manufacturers of sterile products and devices with a measuring function must apply to a Notified Body for certification of the aspects of manufacture relating to sterility or metrology Once the manufacturer is satisfied that his products meet all the relevant Essential Requirements the manufacturer or his European Authorised Representative if the manufacturer is located outside of EEA must

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