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Mar 27, 2020 · The National Health Institute and Confindustria Dispositivi Medici (the Italian Association of Medtech Companies) jointly developed a technical datasheet identifying essential requirements for the placing on the market of surgical masks for medical use not bearing the CE marking pursuant to Article 15 of Decree Law No. 18 of March 17, 2020, so ...

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Based on this comparison, it is reasonable to consider KN95(China GB2626-2006), KF94 (Korea KMOEL - 2017-64) as “equivalent” to N95 (United States NIOSH-42CFR84) and FFP2 (Europe EN 149-2001) respirators, for filtering non-oil-based particles such as those resulting from wildfires, PM 2.5 air pollution, volcanic eruptions, or bioaerosols (e.g. viruses).

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ASTM standards are referenced by the Food and Drug Administration (FDA), as the endorsed standard in the United States. The current standard ASTM F2100-11 (2011) specifies the performance requirements for Medical Face Masks with five basic criteria: 1.

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Apr 13, 2020 · One blogger joked several years ago that CE means “Caveat Emptor”. Funny, but sad and true today. “N95” and Similar Designations: When any mask comes into the United States with N95 marking on it or its box, the manufacturer must be listed on CDC’s site or it is a counterfeit product and is subject to seizure. No product can bear any ...

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Medical Device Directives. In order to bring medical devices to the European (EU) market, manufacturers must earn a CE Mark to confirm compliance with the Medical Device Directive 93/42/EEC (MDD) and its supplementary Directive 2007/47/EEC; or in the case of in vitro diagnostic medical devices, the In Vitro Diagnostics Directive (IVDD) 98/79/EC.. These CE marking Directives cover active ...

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ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives and Regulations.

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Class I reusable surgical instruments fall into this category. ‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused.

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Project Management. Whether you are a European start-up seeking FDA clearance, or a U.S. company seeking CE marking for a product being manufactured in Asia, Eurofins Medical Device Testing is the preferred partner to help navigate the pathway to market.

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b. We have the honor to achieve certification if ISO-9001:2000 Quality Assured Standard. c. Our products are registered for CE marking. d. We are certified for cGMP (FDA-USA) On your specific demand we can accommodate you by sending our latest catalogue.

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ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives and Regulations.

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Class I reusable surgical instruments fall into this category. ‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused.

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Working With Us - Eurofins Medical Device Testing

Project Management. Whether you are a European start-up seeking FDA clearance, or a U.S. company seeking CE marking for a product being manufactured in Asia, Eurofins Medical Device Testing is the preferred partner to help navigate the pathway to market.

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