Unique Device Identification

United States · Last verified: 2026-09-08

Number

21 CFR 830

Type

Regulation

Issuer

U.S. FDA

Status

in_force

Authority

FDA / CDRH

What this covers

UDI 唯一器械标识：UDI 编制规则、器械标识变更与重贴标、发码机构（issuing agency）认可与 FDA 自任发码机构、以及向 GUDID 数据库提交标识数据的内容与时限。

Source: U.S. Food and Drug Administration (public domain)