江苏出口美国医械被FDA通报5条

2019-08-28 作者：NBAMDI 浏览量：245

一、中国出口的电动治疗按摩器被美国FDA通报

通报日期: 2019-07-22

产品类别: 辅助设备类

产品名称: 电动治疗按摩器

产地: 苏州

制造商: SUZHOUPINEAPPLEHEALTHTECH

通报原因: 产品不在510（j）的清单内或未按照510（j）/510（k）的要求提供所需信息

二、中国出口的一次性冷热敷袋被美国FDA通报

通报日期: 2019-07-12

产品类别: 医用材料(ICS:11.120.20)

产品名称: 一次性冷热敷袋

产地: 常州

制造商: CHANGZHOUWENYUMEDICAL

通报原因: 产品不在510（j）的清单内或未按照510（j）/510（k）的要求提供所需信息

三、中国出口的眼镜式放大镜被美国FDA通报

通报日期: 2019-07-12

产品类别: 眼科设备（眼镜、镜片）(ICS:11.040.70)

产品名称: 眼镜式放大镜

产地: 镇江

制造商: ZhenjiangSincereCoLTD

通报原因: 产品不在510（j）的清单内或未按照510（j）/510（k）的要求提供所需信息

四、中国出口的一般手术用手动式器械被美国FDA通报

通报日期: 2019-07-08

产品类别: 外科器械和材料（11.040.30）

产品名称: 一般手术用手动式器械

产地: 苏州

制造商: SuzhouMeccanImp.&Exp.Corp

通报原因: 产品不在510（j）的清单内或未按照510（j）/510（k）的要求提供所需信息

五、中国出口的植入式给药装置被美国FDA通报

通报日期: 2019-07-08

产品类别: 输血、输液和注射设备（11.040.20）

产品名称: 植入式给药装置

产地: 淮安

制造商: WebestMedicalProductsCoLtd

通报原因: 产品不在510（j）的清单内或未按照510（j）/510（k）的要求提供所需信息

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基本文件流程错误 SQL 调试

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江苏出口美国医械被FDA通报5条