FDA UDI

Medical device manufacturers and labelers selling in the US market — from Class I devices to implantables.

A Unique Device Identifier must appear on every device label in both human-readable and AIDC format — QR codes are an accepted carrier. The UDI-DI identifies the device model; the UDI-PI identifies the specific production unit or batch. All UDIs must link to a record in the FDA's GUDID database.

Bulk-generate QR codes encoding UDI data for each device model and production batch. Manage label versions with a full audit trail per serial number. Export records for FDA inspection or notified body review.