software solutions for UDI

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What is UDI?

UDI (Unique Device Identification) bezeichnet die eindeutige Kennzeichnung von Medizinprodukten. War dies bisher eine freiwillige Leistung der Hersteller, so ist diese Kennzeichnung nun durch die US-amerikanische Gesundheitsbehörde FDA verpflichtend vorgeschrieben. Die Pflicht zur Unique Device Identification ist auch für Europa geplant.

intelligently integrated - precisely marked

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Why UDI?

Export to the US

The US Food and Drug Administration (FDA) requires that all medical products are labeled with a unique identification according to the UDI guidelines.

Planned for Europe

The obligation of labeling medical devices is also planned for Europe.

Risc class II in 2017

Instruments, which are categorized as risk class IIb have to be labeled from September 2017. Instruments in risk class III have to be marked from the end of 2016.


risk class III
September 2016 Deadline is about to expire
risk class IIb
September 2017
risk class IIa
September 2018
risk class I
September 2020
* The deadlines refer to the labeling of instruments. The UDI label for packaging has to be implemented two years before this deadline.

Questions? - Answers!

  • What is UDI used for?
    In healthcare, the patients safety has the highes priority. The beasis for this is the consistent identification of medical instruments starting from the manufacturer through retailers and the hospital to the patient. With UDI, medical instruments are labeld with a gobally unique identification. This leads to a complete transparency in the entire supply chain.

    The term "UDI-Compliant" indicates, that a medical device is uniquely labeled.
  • Who requires UDI?
    For anyone who wants to export their products to the American market, sooner or later the UDI policy will be mandatory. Also in the EU it is planned to require the UDI policy for medical products. Therefore, it is reasonable that manufacturers have their medical devices marked for all countries with UDI-compliant code to take advantage of UDI immediately rather than to local legal requirements.
  • What does UDI consist of?
    UDI describes a complete system: UDI consists of a unique code on the product or the packaging. In addition, UDI includes storing the data of medical products in a central database.
  • What has to be labeled?
    Medical devices of risk class I, II and III have to be provided with a globaly unique, machine-readable code (for example a bar code). This code is the key to a database that contains detailed information to the product. The same code is also applied to the smalles packaging size.
  • What does the UDI-Label consists of?
    The marked label must be based on certain standards. Accredited by the FRA are the standards HIBC, GS1 and ISBT. No matter what standard you choose: The label must always consist of a Device Identifier (DI) and a Product Identifier (PI). The DI contains the manufacturer or labeler. The PI is dnynamic and can contain multiple data to the product like the expiration date, the serial number or the date of production. Through the worldwide network GUDID manufacturers can submit the productinformation to the UDI-Database of the FDA.
    With the Schilling marking lasers the standards thar are accredited by the FDA can be complied easily. The special standards HIBC and GS1 can be marked with the Schilling marking lasers.


Die wareconsult GmbH & Co. KG ist ein innovatives IT-Unternehmen aus Tuttlingen, das es sich zur Aufgabe gemacht hat, mit individuellen Softwareentwicklungen Lösungen für Unternehmen zu finden.

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For more than 40 years the family business Schilling Marking Systems GmbH is specialized in industrial marking of metals, plastics and other materials.

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