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    Unique Device Identification

    System for adequate identification of medical devices through distribution and use.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Unique Device Identification (UDI) is a system that uses an alphanumeric code to uniquely identify a medical device through its distribution and use. It comprises a Device Identifier (DI) and a Production Identifier (PI), and is registered in the GUDID (US) or EUDAMED (EU).

    What this means in practice

    UDI supports recall management, adverse event reporting, and supply chain traceability. It is mandatory in the U.S., EU, and an increasing number of jurisdictions.

    Use cases

    1 scenario
    1

    EU MDR labeling refresh across 200 SKUs

    Labeling specialist

    The team assigns UDI-DI/UDI-PI to every SKU using a GS1 issuing agency, prints AIDC and HRI on labels, and uploads device data to EUDAMED. Production scanners verify each label before release.

    OutcomeDevices ship into the EU on time; hospitals can scan UDIs into their inventory and adverse event reports.

    Cross-references

    Contains

    Sub-elements or required artefacts of this term.

    Mentioned in recent activity

    8 entries
    Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671 The MAC Multi-Lumen Central Venous Access Device with Arrowg+ard Blue technology permits short-term (<30 days) venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The Arrowg+ard technology is intended to help provide protection against catheterrelated infections. Clinical data have not been collected that demonstrate the use of the Arrowg+ard antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
    Class II· 2026-03-11
    ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH UDI code: (01)10801902223668(17)261231(11)251210(10)33F25L0144 REF ASK-45854-MGH UDI code: (01)10801902223699(17)261231(11)251209(10)33F25L0145 The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the Arrowg+ard Blue Plus catheter in preventing CRBSIs compared to the original Arrowg+ard Blue¿ catheter has not been studied.
    Class II· 2026-03-11

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    FDA·1IMDRF·1RAPS·1
    1. 1
      UDI System (FDA)
      Verified
      FDAfda.gov
    2. 2
      IMDRF Documents
      Verified
      IMDRFimdrf.org
    3. 3
      RAPS Regulatory Focus
      Verified
      RAPSraps.org

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