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Barcode Better

At TEKLYNX, we believe barcode software isn’t just something you buy. It’s an integrated technology solution that makes your company work.

Products

European Union Medical Device Regulation (EU MDR) Labeling

EU MDR Labeling Software

Easily create and print EU MDR-compliant labels

 

  • CODESOFT for EU MDR label creation
    • Health Industry Barcode (HIBC) and GS1 Databar barcode creation
    • Easy-to-use wizards
    • Create user rights and enable label security controls
    LEARN MORE
  • TEKLYNX CENTRAL CFR for Label Management
    • Pull label elements from a centralized database for EU MDR-compliant labels
    • Automate labeling process with central management to ensure process enforcement and additional control
    LEARN MORE

TEKLYNX CENTRAL CFR: QTS Increases Efficiency by 40% and Achieves UDI Compliance

READ CASE STUDY

About EU MDR

Organizations distributing medical devices throughout the EU must comply with the EU MDR regulation established in May 2017.

 

The EU MDR is designed to ensure public health and patient safety across Europe and to increase quality and transparency of medical devices in the healthcare supply chain through label design, label approval, and label tracking standardization.

 

As a result, all medical device labels, with the exception of custom-made and performance study/investigational devices, will need to bear a Unique Device Identifier (UDI), which includes a Device Identifier (DI), Product Identifier (PI) and Human Readable Information (HRI). Medical device manufacturers and distributors across Europe must adhere to EU MDR labeling standards starting May 2020.

 

Compliance with EU MDR includes:

 

 

EU MDR LABEL SAMPLE

“We have very high confidence in our compliance with UDI standards. I can absolutely say we made the right choice with TEKLYNX.”

- Todd Engelken, QTS

Are You Ready for UDI?

DOWNLOAD EBOOK

Creating GS1 Barcodes in CODESOFT and LABELVIEW

 

Learn how to use the GS1 barcode wizard in CODESOFT and LABELVIEW to create GS1 compliant barcodes

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Need help complying with EU MDR?

Tell us a little about your company and we will be in touch to discuss your EU MDR labeling needs.

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