Unverified50% confidenceDecision RuleTime unknown

选购家用胎心仪务必确认具备NMPA二类医疗器械注册证（械字号），仅有ISO或CE而无国内械字号的产品在国内属于非法定医疗用途，测量准确性无保障

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Unverified购买时务必确认包装标注有NMPA二类医疗器械注册证号，市面上存在仅为普通日用品备案的仿冒产品，无医疗器械注册号的不具备无菌保障83% similar Unverified带FDA/CE-MDR或NMPA二类医疗器械注册证的产品才具备临床级可信度；标注为FDA注册（registration）而非许可（clearance）的属于免临床豁免产品，精度未经监管验证78% similar Unverified缺乏NMPA医疗器械注册证或CE/FDA认证的电极片不建议购买，无认证产品的放电参数和生物相容性无保障；正规产品应能提供医疗器械注册证编号78% similar

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