Clean data in. Accepted records out.
Most GUDID problems don't start in the database. They start earlier, when device data is spread across ERP systems, label files and someone's spreadsheet. We fix that first, then submit for you.
Every project starts with
How we collect UDI data.
Every project starts with a structured data collection template. It covers 81 data elements for each device. We fill it in with you, check it against your labels, and then submit it to GUDID (and EUDAMED) for you.
Device identifiers
Primary DI, packaging levels and quantities
Brand & model
Brand name, version or model, catalog numbers
Labeler
Labeler details, DUNS and contacts
Classification
FDA product codes and GMDN terms
Characteristics
Sterility, MRI safety, storage and handling
Rules
Which fields are required and which changes trigger a new DI
What we do for GUDID.
We act as your third-party submitter to the FDA Global Unique Device Identification Database.
DI record creation
New device identifier records built from validated data, with the right packaging hierarchy.
Bulk uploads & edits
HL7 SPL submissions for larger portfolios, plus edits when your products change.
Data audits & corrections
We audit existing records, find errors and mismatches with your labels, and correct them.
Account setup
Help with your GUDID account, labeler DUNS and submitter access.
Labels that match
Compliant label design, printing and IQ/OQ/PQ, so the label and the record agree.
GUDID questions we hear every week.
Q01What is GUDID?
Q02Who has to submit?
Q03Web interface or HL7 SPL?
Q04What happens when a device changes?
Q05Does the label have to match?
Let's look at your GUDID data.
Book a free 15–30 minute video consultation call. Our team will identify the gaps in your device data, records and labels.
Book a Free Video ConsultationNo obligation. You get a list of the gaps we find, recommended next steps and a clear scope if you want our help.
