Custom Label Printing | UDI Labels for MedTech

Custom Pre-Printed UDI Label Services

Scalable Pre-Printed UDI Label Services for Medical Device Manufacturers

Compliant, high-quality UDI labels delivered ready-to-use. Eliminate the complexity of in-house printing while maintaining 100% regulatory accuracy.

Simplify Your Labeling Workflow without the Hardware Headache

For many regulated manufacturers, maintaining an in-house printing operation is a significant drain on resources. Between capital investment, hardware maintenance, ribbon compatibility, and the risk of unreadable barcodes, the "hidden costs" of in house labeling add up.


GMP Labeling’s pre-printing service provides a "validation-ready" alternative. We handle the technical precision; you get labels that are ready for application.


  • Reduce Capital Expenditure: No need to invest in industrial printers, validators, or specialized software.

  • Scalability and Flexibility: We can scale with you as you grow, for short run to high volume production.

  • Material Expertise: Our labels utilize RoHS, and REACH-compliant materials designed for medical environments and withstand sterilization (Gamma, EtO, Autoclave).

Two Pre-Printing Service Options for UDI Labels

1. Partial Pre-Print (Hybrid Solution)

Best for: Manufacturers who want brand consistency but need to print variable data (Lot/Exp) on the line.


  • What we do: We print your full-color company logo, address, and static device identifiers (DI).

  • What you do: We leave precision-engineered blank space for your thermal transfer printers to add the Production Identifiers (PI) like Batch, Lot, and Expiry.

Example of a UDI label for a hypothetical medical device company

2. Full Turnkey Pre-Print

Best for: Low-to-moderate volume devices or products with stable production data.


  • What we do: We print the entire label—including the DI, PI, and the final UDI barcode.

  • The Result: You receive finished rolls or sheets of labels that are 100% ready for the product or secondary packaging.

Example of a UDI label for a hypothetical medical device company

Engineered for Regulated Industries

We don’t just sell labels or software—we act as your UDI systems partner.


  • Compliance Standards: Our processes align with 21 CFR Part 830 (UDI) and 21 CFR Part 820 (Quality System Regulation).

  • Barcode Formats: We support GS1 DataMatrix, GS1-128, and HIBCC formats.

  • Material Durability: Options include cleanroom-compatible polypropylenes, cryo-resistant adhesives, and chemical-resistant topcoats.

  • Quality Control: As an ISO 9001 certified company, quality is at the core of our business.

Why Global Medical Device Brands Trust GMP Labeling

  • Made in the USA: All labels are manufactured in our domestic facilities for faster lead times and tighter quality control.

  • Customization: From serialized labels to color-coded identification, we build the label around your Device Master Record (DMR).

  • Industry Expertise: We don’t just print; we understand the "why" behind the GS1 check-digit and the AIDC requirements.

Ready to Offload Your UDI Labeling?

Consult with a GMP Labeling expert today to determine which pre-printing path is right for your device portfolio.

Looking for a Software Solution to Design, Manage, and Print UDI Labels?

As a Strategic Partner with Loftware and Zebra, we can custom build a UDI Label Printing Solution for your operation.

Pre-Printed UDI Label FAQ

Pre-printing reduces the risk of compliance errors caused by poor print quality or incorrect software configuration. It eliminates the need for manufacturers to maintain validated printing hardware and specialized staffing, ensuring that every label meets GS1 and FDA standards upon arrival.
Yes. GMP Labeling offers specialized materials and inks validated for Gamma, ETO (Ethylene Oxide), and Autoclave sterilization to ensure the UDI remains legible throughout the product lifecycle.
Absolutely. We provide pre-printed labels for both GS1 and HIBCC Issuing Agencies, ensuring the DI and PI data are correctly encoded in the AIDC (Automatic Identification and Data Capture) format.
  • Why Choose GMP Labeling

    Compliance & Quality You Can Trust

    Leading electronics manufacturers rely on GMP Labeling for dependable quality and labeling solutions that meet stringent industry standards. We use UL-recognized, RoHS, and REACH-compliant materials to ensure your labels adhere to regulatory requirements and maintain product safety.


    Our commitment to consistent quality and reliable supply helps you avoid production delays and costly rework. With deep industry expertise and a focus on compliance, GMP Labeling is your trusted partner for electronics labeling solutions that protect your brand and keep your operations running smoothly.

Made in the USA with Precision and Care

All GMP Labeling cleanroom-compatible labels are proudly manufactured in the United States. Our U.S.-based operations ensure tight quality control, faster lead times, and reliable performance in the most regulated environments.