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.