§ 830.20 - Requirements for a unique device identifier.

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A unique device identifier (UDI) must:

Be issued under a system operated by FDA or an FDA-accredited issuing agency;

Conform to each of the following international standards:

ISO/IEC 15459-2, which is incorporated by reference at § 830.10;

ISO/IEC 15459-4, which is incorporated by reference at § 830.10; and

ISO/IEC 15459-6, which is incorporated by reference at § 830.10.

Use only characters and numbers from the invariant character set of ISO/IEC 646, which is incorporated by reference at § 830.10.