Products
Master Your UDI Data. Everywhere.
One record, global submission. Manage Unique Device Identification (UDI) data for FDA GUDID, EU EUDAMED, and China NMPA in a single hub.
Multi-Market Submission
Direct M2M submission to FDA GUDID and EU EUDAMED. Export support for China, Korea, and Australia.
Label Verification
Ensure your physical label barcodes match your database records with built-in GS1/HIBCC verification.
Change Control
Track every edit to a device attribute (e.g., MRI Safety) with a full audit trail and version history.
The UDI Lifecycle
01
Ingest Data
Import data from your ERP (SAP, Oracle) or PLM system. We clean and validate it against rules.
02
Enrich & Validate
Our system flags missing mandatory attributes for specific markets (e.g., Basic UDI-DI for Europe).
03
Submit & Publish
Push data to GUDID/EUDAMED with one click. Receive acknowledgment receipts automatically.
Hub Capabilities
Supported DBsFDA GUDID, EUDAMED, NMPA, KR-UDI
ValidationHL7 SPL, XML Validation
IntegrationsSAP, NetSuite, PTC Windchill
Barcode StandardsGS1, HIBCC, ICCBBA
SecuritySSO, 2FA, IP Whitelisting
AuditField-level change tracking
FAQ
Q. Do you support Basic UDI-DI?
A. Yes, we fully support the EU MDR Basic UDI-DI hierarchy and linking.
Q. Can I print labels from here?
A. We integrate with labeling software like BarTender and NiceLabel to push approved data.
Q. Is validation included?
A. Yes, the system is validated to GAMP5 Cat 4, and we provide the IOQ package.