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选购医疗监测用途需认准注册证：国内应有二类医疗器械注册证（械字号），出口/海淘产品看FDA 510(k)或CE-MDR认证；仅标'保健用品'或无械字号的属于消费级，不能作为疾病判断依据

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Unverified医疗用途应认准注册为二类医疗器械（有医疗器械注册证号），保健/出行用品属普通消费品无需医疗认证，二者支撑标准差异大，勿混淆购买85% similar Unverified选购医疗级监测仪应认准注册证类别：中国NMPA二类医疗器械注册证、美国FDA 510(k)或欧盟CE-MDR认证，仅标注'CE'但属于CE-MRA消费电子类的产品不代表医疗性能83% similar

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