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IMDRF · International guidance

IMDRF/UDI WG/N48:2019

Unique Device Identification (UDI) System Application Guide
International Medical Device Regulators ForumIMDRFTechnical guidance
International guidance

This document provides international technical guidance. Publication here does not establish its adoption or binding effect in any national market. Check the applicable national requirements and the issuing authority’s latest publication.

Source identity
Issuing body
IMDRF
Reference
IMDRF/UDI WG/N48:2019
Published (source metadata)
March 21, 2019
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Unique Device Identification (UDI) System Application Guide

Practical application guide for UDI system implementation. Covers UDI-DI, UDI-PI, direct marking, and database submission.