FDA UDI, EU MDR and IMDRF-aligned unique device identity secured by NBR — from packaging to point of care.
Industry overview
One Trust delivers a UDI-native identity layer that satisfies FDA, EU MDR and IMDRF while giving hospitals, clinicians and patients an instant authenticity check at point of care.
Counterfeit statistics
Business risks
Counterfeit implants and IVDs directly threaten lives and expose manufacturers to litigation.
EU MDR and FDA non-compliance halts market access.
Without unit identity, recalls become blanket and hospital-disruptive.
Payors increasingly require verified UDI on claims.
How One Trust solves it
Every unit gets a UDI-linked NBR — printed on primary, secondary and unit-of-use packaging. Hospitals scan on receipt, clinicians scan at point of care, and every scan lands in your device master data.
GS1 Digital Link resolvers integrated with GUDID / EUDAMED submissions.
Sterile-barrier compatible printing on Tyvek, PET, and metal.
Non-authentic scan attempts surface geographies and channels.
Auto-populate national implant registries.
Isolate affected lots to specific hospitals within minutes.
See device flow across hospitals and OR suites.
Workflow
Every SKU/lot receives a Non-Reproducible Barcode with cryptographic anchor at print time.
Codes are printed inline at your existing lines — no new hardware, no line slowdown.
Unit → carton → pallet parent-child hierarchy captured across your network.
Consumers, retailers, inspectors and partners scan with any smartphone camera.
Real-time alerts, geo heatmaps and BI feeds flow to your brand-protection team.
ROI
FDA, EU MDR, IMDRF.
In protected markets within 12 months.
Case study
MDR compliance pressure and counterfeit spinal implants surfacing in secondary markets.
NBR + UDI on 12M implants/yr; four counterfeit networks disrupted; MDR-ready EUDAMED feeds live in 9 months.
FAQ
Demo request
Tell us about your SKUs, volumes and markets. An enterprise solutions engineer with deep medical devices experience will get back within one business day.