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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.

    Datasheet Verification                                       Datasheet medical Verifier

Medical engineering

UDI Code - Identification and quality control

The end-to-end traceability of medical devices and the improvement of patient safety play a crucial role in the quality assurance of medical engineering. Unique product identification through UDI-conformant labelling is required for this purpose.

The coding of surgical instruments is also vitally important for a successful instrument management.

The IOSS systems are inherently suitable for reading and evaluating the codes on surgical instruments and medical devices.

Advantages:

  •     Quality management in accordance with stipulated requirements and directives
  •     Complete traceability and documentation of each and every surgical instrument
  •     Monitoring of operating sets
  •     Reliable flow of sterilised equipment
  •     Inventory management
  •     Cost transparency and cost-effectivenessQualitätsmanagement
  •     Compliance with the UDI Unique Device Identification (FDA) guidelines for labelling medical devices 
  •     Verification of laser-marked data matrix codes according to ISO/IEC 29158

Overview of our 2D-Code Reader:

 

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