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Jiangyin Huayou Medical Materials Co Ltd 78 Dongsheng West Road Jiangyin City China : Certification ECM Mark: Product: Disposable protective mask : Model(s): 175*95(mm) 145*95 125*95 : Verification to: Standard: EN 149:2001+A1:2009 : related to CE Directive(s): R 2016/425 (Personal Protective Equipment) Remark: This document has been issued on a voluntary basis and upon

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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)

Medical-surgical disposable protective face mask Bacterial filtration efficiency ≥99% Particular filtration efficiency ≥99% Effectively isolating bacteria pollen dust and haze CE FDA ISO13485 ASTM F2100 Level 1/2/3 EN14683 TYPEI II IIR Customized material color and size are available

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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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