Regulated pack templates
UDI, PPN and serialisation layouts are designed once and reused across every packaging line.
Regulated Identification
Codes that hold up to inspection.
UDI carriers, FMD unique identifiers and DSCSA product codes, generated to specification.
Healthcare identification leaves no room for a symbol that “usually scans” — TEC-IT generates UDI, FMD and DSCSA carriers with the correct data structure, the correct check digits and the print quality the standards call for.
A regulated barcode is a legal document that happens to be printed.
Build the required identifiers into your label and capture workflows.
An FMD unique identifier has to carry product code, serial, batch and expiry in a Data Matrix that meets ISO/IEC 15415 grade 1.5 or better. A UDI carrier has to survive direct marking on a reusable instrument. A DSCSA product identifier has to be readable at every node in the chain. In each case the requirement is not “print a barcode” but “print this data, in this structure, at this quality” — which is exactly what a general-purpose design tool cannot guarantee.
Codes that pass inspection.
Serialised packs, UDI and printing as one system.
Serials verified before release
Each serial, GTIN and expiry is checked against GS1 and regulatory format before release.
Audit-trailed production
Release regulated pack codes to line printers while recording the serialised output for review.
The products behind Healthcare & Pharma.
Every solution maps to proven, licensable products.
TBarCode SDK
Generates 100+ symbologies inside .NET, C++ and COM systems used for healthcare output.
// generate a barcode
var bc = new Barcode();
bc.Type = "QRCode";
bc.Save("out.png");
TFORMer Designer
Builds UDI, PPN and serialised pack layouts for regulated production.
9 012345 678905
Barcode Studio
Creates print-ready GS1 DataMatrix, QR and linear codes for healthcare packaging.
TFORMer Workstation
Prints serialized labels with managed serial number pools.
- Pallet label · SSCC Done
- GHS label · Plant 2 Printing
- Carton label · GS1-128 Queued
Regulated output
Validated data in. Gradable symbols out.
UDI, FMD and DSCSA carriers from the systems you already validate.
26 May 2027
the last EU MDR and IVDR UDI carrier deadlines fall due
Grade 1.5
the minimum FMD print quality per ISO/IEC 15415
20,000+
customers run TEC-IT software worldwide
Audit-ready by design.
Every serial and event is recorded, not reconstructed.
Serials from your system
Numbers come from your L4 serialisation host — the print never invents one.
Logged as it prints
Each aggregation and commission is written to the audit trail as it happens.
Reportable per market
The same run produces the report format each regulator expects.
Customer stories
How companies run identification, labeling and data capture on TEC-IT software – in production, logistics and IT.
Frequently asked questions
Learn more about Healthcare & Pharma.
What print quality does EU FMD require?
The unique identifier must be a GS1 DataMatrix with a minimum print quality grade of 1.5 measured per ISO/IEC 15415. Below that, packs risk failing verification at the pharmacy. TEC-IT generates the symbol with correct AI encoding; grading should still be confirmed with a verifier on your actual material.
What does UDI labeling require beyond the barcode?
EU MDR Annex VI Part C requires both the machine-readable AIDC carrier and the human-readable interpretation (HRI) on the label. TFORMer places both from the same data, so the printed text and the encoded data cannot drift apart.
Does TEC-IT store or report our serialization data?
No — and it is important to be clear about that. TEC-IT is the marking layer: it generates compliant symbols, HRI and serial sequences. It is not a serialization repository, EPCIS platform or national-hub reporting system, and it does not replace one.
What happens when a label misprints mid-run?
You cannot simply reprint the same serial — a duplicate breaks uniqueness and creates an audit gap. TFORMer Workstation manages serial pools centrally so a failed unit is recorded and the next print draws the next valid serial rather than reusing one.
More resources
Guide
GS1 DataMatrix for healthcare packs
Review ECC200 sizes, encoding modes and healthcare applications for regulated pack identification.
GuideGS1 AIs for healthcare identification
Check the structure and meaning of GTIN, serial, expiry and healthcare data fields.
FAQHealthcare barcode creation FAQ
Healthcare barcode guidance covering GS1, check digits and regulated data formats.