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1993 年 6 月 14 日的 93/42/EEC 指令涉及医疗器械,是登士柏西诺德质量管理计划的框架。所有欧盟成员国的国家法律都强制执行指令。该指令面向欧洲经济区(欧盟 + 欧洲自由贸易联盟)内所有医疗器械制造商和分销商,具有相同的要求。根据 DIN EN ISO 13485 认证并根据指令 93/42/EEC 附录 II 提供最高质量、可靠性和可信度的证明。由慕尼黑 TÜV 产品服务技术检验机构进行年度审核,确保我们的质量管理体系不断改进。



Certificate according to EN ISO 13485 498 kB

证书符合 EN ISO 13485

Certificate according to ISO 13485 CMDCAS 129 kB

证书符合 ISO 13485 CMDCAS

EF Certificate 494 kB