UDIs are issued by FDA-accredited or EU-designated issuing agencies. The three most widely used are GS1, HIBCC, and ICCBBA. Manufacturers select an accredited agency and follow its standard to construct their UDIs.

Where are UDIs stored?

In the U.S., UDI data is submitted to the FDA Global Unique Device Identification Database (GUDID) and made public through AccessGUDID. In the EU, UDI data is registered in EUDAMED under MDR and IVDR.

Do Class I devices need a UDI?

Yes, most Class I devices require UDI in both the U.S. and EU, though timelines and specific exemptions differ. Direct marking requirements typically apply to reusable devices that are reprocessed between uses.

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RegulatoryRegulated Pathways Manufacturing & SupplyUDI

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. The Device Identifier (DI) is the fixed portion that identifies the labeler and specific version or model. The Production Identifier (PI) is a conditional, variable portion that may include lot or batch number, serial number, expiration date, manufacturing date, and (for HCT/Ps) the distinct identification code.

Examples

A pacemaker labeled with a GS1-issued UDI containing a GTIN as the DI and lot number plus expiration date as the PI.
An implantable orthopedic screw carrying a direct-part-marked UDI so it remains identifiable after unpacking.

Use cases

1 scenario

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.

Common pitfalls

•Confusing UDI-DI with UDI-PI. Regulators, GUDID, and EUDAMED all expect both to be handled correctly on labels and in submissions.
•Assuming a single UDI covers every package level. Each package configuration (unit, box, case) needs its own DI.
•Not updating GUDID or EUDAMED when labeling, sterilization method, or configuration changes.
•Treating UDI as a labeling-only task. It touches PLM, ERP, regulatory, and post-market systems.

Frequently asked questions

UDI-DI (Device Identifier) is the fixed identifier for a specific device version or model and its packaging level. UDI-PI (Production Identifier) is the variable portion that identifies the specific production unit, typically including lot or batch number, serial number, expiration date, or manufacturing date.

Cross-references

Used by

Things that build on this term.

Contains

Sub-elements or required artefacts of this term.

UDI-DI vs. UDI-PI

Grouped by theme

Editor's picks

· Hand-selected related concepts

Regulatory

EUDAMED

European Database on Medical Devices.

Regulatory

EU Medical Device Regulation(MDR)

Regulation (EU) 2017/745 governing medical devices in the European Union.

Post-Market

Global Unique Device Identification Database(GUDID)

FDA database holding key device identification information for all UDIs.

Post-Market

Post-Market Surveillance(PMS)

Activities to monitor device safety and performance after market release.

EU MDR Essentials

· From this learning path

Regulatory

CE Mark

Mandatory European conformity mark for medical devices placed on the EU market.

Regulatory

EU In Vitro Diagnostic Regulation(IVDR)

Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.

Regulatory

Notified Body(NB)

EU-designated organization that assesses conformity of medical devices under MDR and IVDR.

Post-Market

Periodic Safety Update Report(PSUR)

Periodic EU MDR/IVDR report summarizing post-market surveillance findings.

Adjacent lesson

Mentioned in recent activity

11 entries

COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN, LGT) and twist-lock connectors. These Shiley Tracheostomy Tubes have a radiopaque, biocompatible outer cannula constructed of polyvinyl chloride.

Class II· 2026-04-15

LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code: 00883873834329 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.

Class II· 2026-04-13

Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.

Class II· 2026-04-09

MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 The MAC Multi-Lumen Central Venous Access Device permits short-term (<30 days) venous access and catheter introduction to the central circulation.

Class II· 2026-03-11

FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code: (01)10801902209853(17)270831(11)251210(10)33F25K0409 The Arrow Epidural Catheter kit permits access to the epidural space for administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours. The Arrow Combined Spinal Anesthesia and Epidural Catheterization products permit access to subarachnoid and epidural spaces. The Arrow Single Shot Epidural product permits access to the epidural space..

Class II· 2026-03-11

Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks.

Class II· 2026-03-11

PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 The Arrow¿ percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.

Class II· 2026-03-11

ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 REF ASK-04020-EUH2 UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869 REF ASK-04020-FMC UDI code: (01)10801902212099(17)270731(11)251218(10)33F25J0870 REF ASK-04020-MMC UDI code: (01)10801902117769(17)271130(11)251211(10)33F25J0880 The Arrow Arterial Catheterization Device permits access to the peripheral arterial circulation or to other small vessels.

Class II· 2026-03-11

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

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On this term

Category: Regulatory
Acronym: UDI
Sources: 3
Use cases: 1
Updated: 5/5/2026

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Learn in 60 seconds

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

·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.
·The Device Identifier (DI) is the fixed portion that identifies the labeler and specific version or model.

Remember this

Watch out: Confusing UDI-DI with UDI-PI. Regulators, GUDID, and EUDAMED all expect both to be handled correctly on labels and in submissions.

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