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.
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).
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.
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.
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.
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.
Consult with a GMP Labeling expert today to determine which pre-printing path is right for your device portfolio.
As a Strategic Partner with Loftware and Zebra, we can custom build a UDI Label Printing Solution for your operation.
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.
Reach out and get in touch.
(800) 637-4487
sales@gmplabeling.com
5955 Granite Lake Drive Suite 150 Granite Bay, California 95746