What does UDI mean?

UDI (Unique Device Identification) is a worldwide system for uniform product labeling of medical devices, that was developed in the USA, UDI is intended to sustainably improve the safety and quality of medical devices. UDI consists of three components:


UDI includes a Device Identifier (DI) and a Production Identifier (PI). The DI is a fixed, ISO-based code for identifying the article and the manufacturer. Variable data such as serial and batch numbers or the expiration date are stored in the PI.


The UDI data carriers are primarily labels. The UDI marking must be machine-readable - for example as 1D or 2D barcode in the GS1 or HIBC standard - and in plain text on the product and / or packaging.


Certain product information must be recorded centrally in the Global Unique Device Identification Database (GUDID). Products can be researched unambiguously in the database via the UDI. The database is publicly available and can be used by patients and doctors.

Example UDI label v3

Your advantages: UDI with KUMAVISION

Increased patient safety
Legally binding marking
Accelerated workflows
Everything in an ERP software
Improved label quality

Complete traceability
Simplified logistics processes
Standardized, worldwide procedure
Optimized approval processes
Simplified device maintenance

Contact

Siegfried Kratsch

Siegfried Kratsch

+49 711 16069550

KUMAVISION ERP: UDI complete in an ERP software

The integrated ERP software from KUMAVISION for medical technology and the healthcare market offers retailers and manufacturers (distributors) comprehensive support in complying with all UDI requirements.

All divisions in an ERP software:

  • Purchasing, Sales, Production, Warehousing & Logistics, Quality Management, Finance and Controlling
  • All data available in all process steps
  • FDA- and MPG-compliant product labeling already included in the standard
  • Extended master data maintenance for the requirements of UDI (article and manufacturer designations, storage conditions, sterilization procedures, lot sizes, etc.)
  • Automatic generation of variable data (serial and batch number, expiry date etc.)
  • UDI-compliant product labeling
  • Label interface (NiceLabel required) directly from the software
  • Data export for GUDID message

KUMAVISION maps UDI directly in the ERP software. All information is managed centrally in the industry software. This forms the basis for lean processes and maximum transparency - not only at UDI.

Automatic label printing from the software

KUMAVISION also supports companies in label printing with integrated processes. The ERP industry software for medical technology based on Dynamics NAV (Navision) prepares the necessary data for the UDI-compliant product labeling and transmits it via an interface to a label printing program that handles the layout of the labels and the control of various printers. GS1 and HIBC are supported. The printing or the transmission can be done directly from the processes, sometimes even automated. Especially practical: For different products, individual labels (design, size, material) can be managed in the software.

Print UDI labels directly from the software
GUDID upload

Simple GUDID upload

The FDA's UDI directive requires distributors to enter certain product characteristics in the publicly accessible GUDID database. KUMAVISION simplifies the GUDID upload: The ERP software generates an XML file (in the corresponding HL7 format) that can be uploaded to the portal without further conversion. In addition, KUMAVISION plans to offer the direct upload from the industry software as a service in the future, so that even a high number of articles can be reported easily.

Optimized logistics chain

The barcodes required for Unique Device Identification (UDI) (GS1 and HIBC Standard) offer great potential for optimizing warehouse and logistics processes. Already in the goods receipt and goods issue can be with scanners z. For example, enter serial and batch numbers and the expiration date and transfer them directly to the ERP system. This saves companies time and reduces the error rate by eliminating the need to manually collect information.

Logistics with barcode and scanner
USA and EU

Perfectly prepared for UDI

With ERP software from KUMAVISION, manufacturers and distributors of medical products are perfectly prepared for UDI - not only for export to the USA. Since UDI will soon be implemented in the EU under the definition "system of the unique product number", the product labeling will prevail nationwide. Rely on UDI and benefit from numerous optimization potentials in a timely manner. At the same time, KUMAVISION and Microsoft Dynamics NAV (Navision) offer you maximum investment and future security.

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