CERTIFICADO CE
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The document certifies that medical devices manufactured by SHAMAN GROUP comply with European Union directives and can bear the CE marking. The devices are classified as Class I reusable, non-powered devices that do not penetrate the body. The technical file for the products was assessed under the Module A conformity assessment procedure. The certificate is valid for one year from the initial issue date of March 14, 2016, provided the manufacturer informs the certifying body of any substantial product or process changes.
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