Every medtech manufacturer, importer, and authorized representative selling into the EU has to be on the actor + UDI/Device modules of EUDAMED. Most Reynosa maquilas and their OEM customers don't have the data structured. Cruzar captures it during your cross-border events.
The EU has EUDAMED. The US has FDA UDI / GUDID. Mexico's maquila layer has neither — yet ships into both markets. Cruzar Ticket already captures HS classification, country of origin, supplier breakdown, and regulatory submissions on every cross-border event. Add UDI-DI/PI capture during the Ticket pass and you have an EUDAMED-ready record by default. We prepare; your OEM's compliance team submits.
Tell us your actor role (manufacturer, AR, importer, distributor) and one device. We tell you what EUDAMED requires + what's missing. No signup.
Each Cruzar Ticket can carry an EUDAMED block: UDI-DI, UDI-PI, GMDN, risk class, NB ID, CE marking.
JSON for actor registration. CSV for UDI/Device module. Your OEM compliance team uploads to EUDAMED — Cruzar never submits on your behalf.
Every Ticket Ed25519-signed and time-stamped. If a competent authority audits the actor or device data, the chain of custody is provable.