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    • Quality control for UDI codes on medical devices & implants

    The verification of direct marked Data Matrix codes is performed in accordance to the current standard ISO/IEC 29158:2025.

    The DMR210 system provides reliable and repeatable quality grading of your Data Matrix codes. Thanks to standard-compliant illumination, accurate quality assessment is also possible on highly reflective and curved surfaces. Module sizes ranging from 100 µm to 300 µm, as defined in the GS1 specification for direct part marking can of course be inspected.

    In addition, the "Q-Report" documentation software enables you to generate proof of the delivered code quality and readability for your end customer. A GS1 format check and modul size check is also included.

    Quality grading, in conjunction with the Q-Report, is carried out within the standardized reflectance range (Mean Light Value – ML). Of course, the system will be calibrated using an official calibration card before delivery and you will receive a calibration certificate for possible validation purposes.

    Marking plastic parts is often challenging: low contrast, reflections, and “gray-on-gray” effects can make 2D code verification unreliable. Our interchangeable 45° lighting creates clear contrast and ensures stable, reliable code verification — especially on plastic surfaces.

    Datasheet Verification                             Datasheet medical Verifier                          Quality Report

Medical engineering

UDI Code - Identification and quality control

The unique identification of medical devices through UDI-compliant labeling supports traceability throughout the product lifecycle. High-quality UDI codes are also an important foundation for efficient instrument management.

The IOSS Verifiers quickly and reliably verify the quality of 2D codes. They are suitable for quality inspection of UDI codes on implants, surgical instruments, medical devices and product labels.

Areas of Application:

  •     Support for quality control in accordance with applicable regulatory requirements (e.g., FDA, MDR)
  •     Support for traceability through code quality verification
  •     Support for monitoring the contents of sterilization containers
  •     Support with instrument reprocessing and logistical processes in the field of sterilization
  •     Support for inventory management of medical devices and implants
  •     Verification of GS1 markings on medical devices and labels
  •     Quality verification of Data Matrix codes according to the standards ISO/IEC 29158 or ISO/IEC 15415

Overview of our 2D-Code Reader:

 

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