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Clean room production hall Automated production line Manual production line Modern storehouse CAD XML-based information system The product quality is assured by holding the DIN EN ISO 13485:2003 and Annex V of Directive 93/42/EEC certificates given by the certification institute DQS Frankfurt am Main as well as the CE quality mark FDA certification is in progress Our products include

3M™ Particulate Respirator 8210 N95 160 EA/Case

During the public health emergency of the COVID-19 pandemic these standard N95 "industrial" respirators may be used by healthcare professionals according to the U S FDA's Emergency Use Authorization (EUA) 3M™ Particulate Respirator 8210 is not cleared by the U S FDA as a surgical mask as a surgical mask and is not considered fluid resistant therefore a face shield must be worn

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Clean room production hall Automated production line Manual production line Modern storehouse CAD XML-based information system The product quality is assured by holding the DIN EN ISO 13485:2003 and Annex V of Directive 93/42/EEC certificates given by the certification institute DQS Frankfurt am Main as well as the CE quality mark FDA certification is in progress Our products include

Frank joined Nitritex in August 2006 as General Manager before being appointed Commercial Director in 2014 responsible for operations logistics commercial and technical customer service support and liaison for European activities Prior to joining Nitritex Frank was Purchasing Director for one of the largest suppliers of single-use gloves to the UK National Health Service Frank's

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CE marking is only obligatory for products for which EU specifications exist and require the affixing of CE marking Some products are subject to several EU requirements at the same time You must make sure that your product complies with all the relevant requirements before affixing the CE marking to it

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BARRIER Medical face masks

BARRIER Medical face masks are designed to reduce transfer of bacteria and particles from medical personnel to the patient reducing the risk of infection Our BARRIER face masks have a high level of bacterial filtration efficiency that reduces the spread of bacteria to the air in the operating theatre

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RECON Recon: FDA rejects AbbVie eye drug BLA Novartis Alcon to pay $347M to settle bribery investigations 26 June 2020 Welcome to Regulatory Reconnaissance your daily regulatory news and intelligence briefing REGULATORY NEWS EMA recommends eight new medicines refuses one 26 June 2020 A committee of the European Medicines Association (EMA) recommended that eight new

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3M™ Particulate Respirator 8511 N95 is a disposable particulate respirator that is designed to help provide reliable respiratory protection of at least 95 percent filtration efficiency against certain non oil based particles The respirator is designed for use for particles such as those from grinding sanding sweeping sawing bagging or other dusty operations This respirator can also

Australian Regulatory Guidelines for Medical Devices V1 1 May 2011 Page 3 of 331 Version history Version Description of change Effective date V1 0 Initial publication 28/04/10 V1 1 • Updated references and contact detail s to reflect TGA's new organisational structure post TGA21 • Made multiple amendments and additions in Section 3 Essential Principles Principle 14 —Clinical

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