UDI data, done right. Every market.
We collect, validate and submit your device data to FDA GUDID, EU EUDAMED and Australia's AusUDID, and make sure your labels match it. One team, one point of contact, so your products stay on the market and your people stay on product.
No registration, no EU market.
Actor registration and SRN, Basic UDI-DI, complete device data and labels that match, all before the deadline.
Installed right. Works right. Prints right.
Label design, printer & BarTender setup and 22-test IQ/OQ/PQ validation, checked against your GUDID and EUDAMED data.
Explore label printing FREE TOOL · 2 MINUTESAre you ready for EUDAMED?
Answer 8 quick questions. Get your readiness score and top gaps instantly, plus a full gap report.
Take the readiness check REGULATORY UPDATE · 2026Apple is now a regulatory checkpoint.
What medical device apps must declare and prove on the App Store in the US, UK and EEA.
Read the updatePaste any GS1 UDI to decode it and check the GTIN check digit in seconds.
Services
End-to-end UDI support, from assigning identifiers and designing labels to submitting and maintaining your records in each regulator's database.
FDA GUDID Submissions
We act as your third-party submitter to the FDA Global Unique Device Identification Database.
- Device Identifier (DI) record creation
- Bulk uploads (HL7 SPL) and edits
- Data audits and error correction
EU EUDAMED Registration
Get your Basic UDI-DI and UDI-DI data into EUDAMED before the November 28, 2026 mandatory deadline.
- Actor (SRN) registration support
- Basic UDI-DI & UDI-DI data entry
- XML bulk upload / M2M preparation
Australia TGA AusUDID
Prepare and submit your device records to the TGA's Australian UDI Database as a third-party data provider for your sponsor.
- Class III & IIb records now required
- Sponsor coordination (30-day window)
- Data mapping from GUDID/EUDAMED
UDI Label Design & Printing
Compliant labels for the U.S. and EU markets, designed, printed and validated (IQ/OQ/PQ) to spec.
- EU MDR/IVDR symbols (ISO 15223-1)
- GS1 barcodes & human-readable UDI
- Artwork review and print runs
- Printer & BarTender IQ/OQ/PQ
FDA U.S. Agent
Foreign manufacturers need a U.S. Agent for FDA establishment registration. We serve as your U.S. point of contact with the FDA.
- Establishment registration support
- FDA communications handling
- Annual renewal reminders
UDI Data Maintenance
Product changes, new SKUs and label revisions kept in sync across every database you're listed in.
- Ongoing record updates
- Multi-market data consistency checks
- Compliance status reporting
Why Global UDI
Regulatory data work is detailed, repetitive and unforgiving. We make it predictable.
One data set, three markets
We build your UDI data once and map it to the FDA, EU and TGA formats, so you don't have to maintain three versions.
Deadline-driven
We track every regulatory milestone for your device classes and plan the work back from the date.
Labels and data together
Your label artwork and database records match, which avoids the most common audit finding.
Fixed, transparent pricing
Clear per-record and per-project quotes, with no surprise hourly billing.
How it works
A simple four-step engagement, from first call to accepted records.
Free video call
In a free 15–30 minute video consultation, we review your device portfolio, markets and current UDI status, and identify any gaps.
Data collection
We send a simple template and collect your device attributes, GTINs and label artwork.
Build & validate
We prepare the records and labels and validate them against each regulator's rules before anything is submitted.
Submit & maintain
We submit, confirm acceptance and keep your records current as your products change.
Key compliance deadlines
Missing a UDI deadline can block your device from the market. Here's what's coming up.
Australia AusUDID: Class III & IIb
A UDI on the label and a record in the AusUDID are now required. Sponsors must submit records within 30 days of supply.
EU EUDAMED: mandatory UDI/Device registration
Use of the EUDAMED UDI/Device module becomes mandatory. Devices must be registered for continued placement on the EU market.
Australia AusUDID: Class IIa
UDI labeling and database records extend to Class IIa medical devices.
Australia AusUDID: Class Is and IVD Class 3 & 4
Sterile Class I devices and higher-risk IVDs come into scope.
Australia AusUDID: IVD Class 1 & 2
Remaining IVD classes come into scope. Direct marking requirements are phased in through 2030.
Free resource library
Brochures, blank IQ/OQ/PQ protocol templates, checklists and videos, all free to download.
Label Printing Services
The full brochure.
EUDAMED Checklist
8 boxes to tick before Nov 28.
Apple Medical Apps 2026
New App Store requirements.
Blank Protocols
IQ, OQ & PQ templates.
The parent company for global device-data compliance
Global UDI is the parent company for a family of regulatory data services built for medical device manufacturers, distributors and authorized representatives. We bring UDI data, labeling and regulatory submissions together under one roof.
Our team works across the U.S., European and Australian frameworks every day, so you get one accountable partner instead of a different vendor for each market.
Talk to our teamGet compliant before the deadline
Book a free 15–30 minute video consultation call. Our team will identify the gaps and tell you exactly what each market requires for your devices.
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.
