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唯一器械标识UDI可以说是医疗器械的身份证，它是由一串数字代码组成，对医疗器械具有唯一识别性，便于之后的产品追溯。
欧盟UDI实施的流程可以分为五步，如下：
1、申请并获取厂商代码
2、编制UDI-DI
3、编制UDI-PI
4、制作UDI 一维、二维条码或RFID标签
5、EUDAMED UDI数据库申报
UDI-DI组成包括：包装标识符+厂商识别代码+商品项目代码+校验码，具体如下：
开头 “（01）”为 DI 指示符，固定不变。
注意！UDI-DI不能超过14位。
商品项目代码由企业自行制定规则编制，编码时要充分考虑不同的产品，同一产品的不同型号，不同包装规格。
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