UDI Checker Guide – Easily Verify Your Medical Device Unique Identifier

What is UDI (Unique Device Identification)?

UDI (Unique Device Identification) is a globally mandated identification system for medical devices, required by FDA, EU MDR, and other regulations. It comprises a Device Identifier (DI) – static information such as manufacturer and model – and a Production Identifier (PI) – dynamic data like lot number, serial number, and expiration date. The DI is typically a GTIN (Global Trade Item Number) under GS1 standards. This UDI Checker validates the DI part’s format and check digit based on GS1 rules.

How to Use This UDI Checker?

1. Enter the UDI string (either the numeric DI alone or the full GS1 application identifier format with parentheses).
2. Click “Validate” – the tool automatically extracts the DI, checks length, character set, and computes the Mod 10 check digit.
3. View the result: the system will tell you if the DI is structurally valid, indicating the core correctness of the UDI.

This tool is completely free and is ideal for medical device registration specialists, hospital procurement teams, and quality regulatory bodies.

Frequently Asked Questions

1. Does a valid UDI guarantee that the device is actually registered and active?

This UDI Checker only verifies the structural validity of the DI (GS1 compliance). A “valid” result means the identifier is correctly formatted. To confirm real‑world existence and registration, you must query the GUDID (FDA Global UDI Database) or EUDAMED.

2. Why does my input with parentheses show as invalid?

In GS1 format, DI is identified by “(01)”, and PI uses “(17)” (expiration), “(10)” (lot), “(21)” (serial). The tool parses the digits following the most common “(01)”. If your string deviates from this pattern, try entering only the DI part (plain numbers) for validation.

3. Does it support other issuing agencies like HIBCC?

Currently we focus on GS1. Support for HIBCC, ICCBBA, and others may be added in future based on demand.

4. Is there any charge for using this tool?

No, it is completely free.

If you have further questions, feel free to contact us via the footer. Thank you for using our UDI Checker!