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GS1 DataMatrix: the global standard for product identification in healthcare

GS1 DataMatrix: the global standard for product identification in healthcare

Table of Contents

In a highly regulated and increasingly digital healthcare environment, accurate identification of medical and pharmaceutical products is essential to ensure traceability, patient safety, and compliance with international regulations. The use of two-dimensional barcodes, such as the GS1 DataMatrix, has become the most effective standard for product identification in the healthcare sector.

At Macsa ID, specialists in laser marking and traceability, we explain why GS1 DataMatrix is now the most reliable solution for the pharmaceutical and medical device industries.

Why is automatic identification important in healthcare?

The traceability of medicines and medical devices plays a critical role in both patient safety and the management of supply chains. Automatic identification systems using barcodes allow key product data—such as batch number, expiry date, and serial number—to be captured quickly and accurately.

Without standardized and high-quality coding, clinical and logistical processes can become inefficient, risky, or even dangerous.

Advantages of GS1 DataMatrix for healthcare products

The GS1 DataMatrix is a globally recognized 2D barcode offering multiple advantages over traditional linear barcodes:

  • High data capacity in a compact space: ideal for small or space-limited packaging.
  • Direct marking on the product or packaging: especially useful for medical devices and primary packaging.
  • High tolerance to damage or printing errors: thanks to built-in error correction algorithms.
  • Global regulatory compliance: adopted in over 75 countries to ensure product traceability across pharmaceutical supply chains.

Regulatory requirements supporting the use of GS1 DataMatrix

The adoption of GS1 DataMatrix is also driven by an expanding international regulatory framework. Countries including Brazil, the United States, Saudi Arabia, India, and the European Union require its use under regulations such as:

  • UDI (Unique Device Identification) for medical devices
  • Pharmaceutical traceability and serialization regulations
  • Post-market surveillance and pharmacovigilance frameworks

Major global health organizations and funding bodies, such as the WHO, UNDP, and the Global Fund, also mandate GS1 DataMatrix on the medical and pharmaceutical products they procure.

Macsa ID solutions for the healthcare sector

At Macsa ID, we deliver laser marking and industrial coding solutions tailored to the needs of the healthcare and pharmaceutical industries:

  • High-precision printing of GS1 DataMatrix codes on various substrates and packaging types.
  • Non-contact laser technology suitable for sterile or sensitive materials.
  • Integration with UDI and pharmaceutical serialization systems.
  • Technical consulting to ensure GS1 compliance and smooth integration with hospital and logistics scanning systems.

Do you need help?

Do not hesitate to contact us for further information about our products, solutions and our company. Your comments and suggestions are really appreciated.

Call us at +34.93.873.87.98 or fill in the form with your data.

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