UDI Barcode Basics: A Guide to Unique Device Identification
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How the UDI Barcode Improves Traceability, Compliance and Market Access
Summary: The FDA Unique Device Identification (UDI) Barcode is essential for medical device traceability, safety, and regulatory compliance. A UDI barcode tracks devices across their lifecycle, supports faster recalls, secures supply chains, and streamlines international compliance. For manufacturers, understanding UDI barcode requirements ensures high-quality standards, efficient labeling, and quicker market access.
What is a UDI Barcode?
UDI (Unique Device Identification) is a globally recognized, numeric or alphanumeric code assigned to a medical device to clearly identify them throughout their lifecycle—from manufacturing through distribution to patient use. It uniquely identifies each device model and, when applicable, individual production units.
Each UDI contains two core parts: the Device Identifier (DI), which links the product to its manufacturer and model, and the Production Identifier (PI), which records variable details such as batch, serial number, manufacturing date, and expiration date For a Human Cell, Tissue or Cellular or Tissue-Based Products (HCT/P) regulated as devices, a unique code links the product to its donor.
What is the Format for UDI?
The device labeler must display UDIs in two formats: first, in plain text that is easily readable; and second, in a machine-readable form that uses automatic identification and data capture (AIDC) technology.
Where is UDI used?
Many jurisdictions require UDI systems—for example, the United States, the European Union (MDR/IVDR), China, South Korea, Saudi Arabia, Taiwan, and others—all follow guidance from the International Medical Device Regulators Forum (IMDRF). The United States enacted this requirement on September 27, 2007, through the Food and Drug Administration Amendments Act (Section 226).
Who Issues and Labels UDIs?
FDA‑accredited organizations such as GS1, HIBCC, ICCBBA, and IFA issue UDIs and generate standardized DI segments according to global and regional rules.
The labeler must apply the UDI or ensure that someone applies it. Typically, the manufacturer applies the UDI; however, kit assemblers, repackagers, relabelers, or reprocessors may also apply it.
How UDI Works
Assignment – First, accredited issuing agencies, such as GS1 or HIBCC, assign a unique device identifier (UDI) to each medical device.
Marking – Next, manufacturers place the UDI on device labels and packaging, using both human-readable text and machine-readable formats like barcodes or QR codes.
Data Submission – Then, device labelers submit the UDI information to regulatory databases, such as the Global UDI Database (GUDID) in the U.S.
Access & Traceability – Finally, authorized users retrieve device information from the database, which enables medical device traceability, supports inventory management, and streamlines recall processes.
How UDIs Must Be Displayed
- Human-readable text: Clear and legible on device labels or packaging.
- Machine-readable format: Via AIDC technologies such as barcodes (e.g. 2D codes like GS1 DataMatrix) or RFID, which allow automated scanning into electronic records.
- For reusable devices that require reprocessing, the labeler must directly mark the DI and PI on the device itself, unless an exemption applies.
For example, below is a unique device identifier (UDI) issued by GS1, an FDA-accredited agency. It uses a 1D barcode for machine readability and beneath is Human Readable Barcode which is: (01)12345678901234(17)140102(11)100102(10)A1234(21)1234
The numbers in parentheses designate different parts of the UDI
- Device Identifier (DI) is 12345678901234
- Production Identifiers (PI) show this detail:
-Expiration Date: 140102
-Manufacturing Date: 100102
-Lot Number: A1234
-Serial Number: 1234
Database Submission & Traceability
The FDA’s Global Unique Device Identification Database (GUDID) functions as a reference for all devices with a unique device identifier (UDI). GUDID/Access GUDID
Device labelers must submit information to the FDA-administered GUDID. When manufacturers submit device data, the GUDID records a standard set of identifying elements tied to the UDI. The database keeps only the Device Identifier (DI), which serves as the key to unlock detailed device information. Although the GUDID excludes Production Identifiers (PIs), it specifies which PIs appear on the device label. GUDID updates data every business day, allowing users to search for or download the most up-to-date information from the site.
Several GUDID data elements match information shown on device labels. The figure below, from the Access GUDID website, illustrates this connection, and additional details are available on the FDA’s UDI website
Before submitting information to GUDID, device labelers must request a GUDID account. Details are available in the section Request a GUDID Account | FDA.
For guidance on accessing and submitting UDIs through the database, refer to the Global Unique Device Identification Database (GUDID) | FDA.
When to Use the AccessGUDID Database
The FDA partnered with the National Library of Medicine (NLM) to launch AccessGUDID. As a result, this searchable database gives patients, caregivers, healthcare providers, hospitals, and industry easy access to device identification information. The AccessGUDID database includes the field for Global Medical Device Nomenclature (GMDN) Code along with the status of the GMDN Code, Active or Obsolete. These fields appear in AccessGUDID and the open FDA Unique Device Identifier endpoint and provide the end user with enhanced search and retrieval capabilities for GUDID data.
Using AccessGUDID, you can:
- Search for devices quickly by device name, company, or Device Identifier (DI)
- Conduct advanced searches using combinations of other fields in the database
- Download GUDID data and export search results.
Note: AccessGUDID does not store user- or patient-specific data, protecting personal privacy.
Why the UDI Barcode Matters in the Medical Device Industry
1. Enhanced Patient Safety & Error Reduction
UDI enables precise device identification at the point of care—reducing risks associated with misused or mismatched devices. When integrated into clinical systems, clinicians can confirm device details instantly, helping prevent adverse events and enhancing patient safety.
2. Faster, More Accurate Recall Management
In the event of a safety issue, UDIs allow manufacturers and healthcare providers to pinpoint exactly which devices (by model, lot, serial) are affected. This enables targeted recalls, limiting patient exposure and reducing operational disruption.
3. Full Lifecycle Traceability
UDI supports tracking of medical devices throughout their entire lifecycle—from manufacturing through distribution to patient use. This end-to-end traceability improves supply transparency and accountability.
4. Secure Supply Chain & Anti-Counterfeiting
By embedding traceability into packaging and databases, UDI helps deter counterfeit devices from entering the market and supports secure redistribution during emergencies.
5. Streamlined Inventory Management
UDI enables automated tracking of stock levels, lot expirations, and usage. This reduces manual data entry, minimizes waste, and improves replenishment accuracy in healthcare facilities.
6. Better Post-Market Surveillance & Safety Monitoring
Regulators and manufacturers can aggregate UDI data to detect device performance issues, track adverse events, and respond more quickly to emerging safety signals.
7. Data-Driven Research & Claims Analysis
Including UDI-DI in insurance claims data creates opportunities for longitudinal study of device outcomes—comparing performance, durability, and failure rates at scale, similar to drug studies. This supports value-based care and device innovation.
8. Regulatory Compliance & Global Market Access
UDI implementation is mandated by key global regulators—including FDA (via GUDID), EU MDR/IVDR (via EUDAMED’s Basic UDI-DI), Brazil’s ANVISA, Australia’s TGA, and others. Conformance enables global product access and keeps organizations audit ready.
9. Standardized Interoperability & Harmonization
UDI relies on global issuing agencies (GS1, HIBCC, ICCBBA) and aligns with global nomenclatures like GMDN, enabling standard data exchange across health systems, vendors, and international boundaries.
10. Cost Savings & Operational Efficiency
By automating identification, recalls, and billing workflows—and reducing manual record‑keeping—UDI systems deliver measurable ROI through reduced labor costs, improved billing accuracy, fewer inventory errors, and better supply use.
In conclusion, understanding the importance of the UDI Barcode system is essential for medical device manufacturers to ensure compliance and facilitate market entry. Need guidance on the UDI Barcode? Contact the EnPak LLC Team–we’re here to help.
Additional Resources:
AccessGUDID
FDA UDI Basics
FDA UDI Website for more information about GUDID data elements
Food and Drug Administration Amendments Act (Section 226) of 2007
FDA Benefits of a UDI System
Medical Device Label Illustration Reference
Submit Data to GUDID
