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Unique Device Identifier

The unique device identifier (UDI) is a mandatory unique number on a medical device that identifies a device at the point of distribution and at the point of use. The UDI consists of the following:

Global Trade Item Number (GTIN) + Application Identifier (AI) = UDI

Our UDI is placed on each medical device using direct part marking (DPM) device in a 2D data matrix format. The data matrix is also printed on each product label. Direct part marking requirements do not apply to any device. The criteria are:

  • DPM must not interfere with the safety or effectiveness of the device
  • DPM is not required for single use devices
  • Device has been marked under 21 CFR 801.45(a)
  • DPM is technologically not feasible.

Our medical device UDI’s have been validated by GS1 Australia and are in accordance with IMDRF UDI guidance IMDRF/UDI WG/N8FINAL:2013.

We also can apply a UHF RFID tag to our instruments and/or your current instrument range. We encode each tag with an EPC, the UDI and any other vital information you wish to store about your instrument. Our tags last over 2500 autoclave cycles. For more information, please contact us.

Feedback & Complaints

We take our products and services very seriously and welcome feedback from our clients. If you have feedback or a complaint, simply complete all fields to the best of your knowledge.  You will be contacted within 48 hours.  Thank you for your patience and cooperation.

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