UDI labelling of our products

2D code: easier device identification – automatic data scanning

We are currently integrating the new UDI code on our labels as part of the Unique Device Identification (UDI) System. UDIs are required only in the United States so far, but will become mandatory in Europe when the new IVDR comes into effect.

This code allows you to scan key information about our devices electronically. 


Examples of UDI codes:

UDI Code Example - ChromsystemsUDI Code Example - Chromsystems
UDI Code Example - ChromsystemsUDI Code Example - Chromsystems

The two-dimensional code replaces our former barcode and contains the following details

UDI Code Information Comment
(01) GTIN (Global Trade Item Number) Uniquely identifies the item all over the world
(10) Batch number  
(17) Shelf-life To the exact day in a YYMMDD format
(11) Manufacturing date To the exact day in a YYMMDD format,
If a shelf-life cannot be specified for a particular device, the manufacturing date is given instead.
(240) Chromsystems order number  

The codes (01) (10) (17) and (11) are compulsory for UDIs, the specification of our article number is an additional service for you.
To scan the code, you will need a 2D scanner that is able to scan data matrix formats. A suitably equipped mobile phone also does the job.

Please note:

During the period of transition, your delivery may contain devices with and without UDI coding. The labelling meets all the applicable transition deadlines.


Symbols on our labels - Recognise important information easily

Apart from the UDI code, we introduce further symbols according to EN ISO 15223-1 in addition to the symbols you already know. They are also explained in our instruction manuals.

Symbol Meaning Usage
Manufacturer Manufacturer On all labels (if the size allows)
Manufacturing date Manufacturing date If no expiry date is specified
Sufficient for <n> appliances Sufficient for <n> appliances On the labels of our assays
Serial number Serial number On the labels of our columns
V1.0 Version number Printed close to the 2D Code
CE0123 CE marking of conformity Conformity assessment by notified body (TÜV Süd Product Service GmbH)

You already know the following symbols. They have been listed and explained in our instruction manuals for some time.

Symbol Meaning Usage
use by Use by Products with expiry date
Order number Order number All products
Batch/Lot code Batch/Lot code All IVD products
In-vitro diagnostic medical device In-vitro diagnostic medical device All IVD products
See instructions for use See instructions for use All IVD products
Upper temperature limit Upper temperature limit Store below a certain temperature
Temperature limit Temperature limit Store within a certain temperature range
Caution Caution Added for products containing human blood, urine or saliva

Examples of different labels

UDI Label for Calibrator Set - ChromsystemsUDI Label for Calibrator Set - Chromsystems
UDI Label for Analytical Column - ChromsystemsUDI Label for Analytical Column - Chromsystems

Please note:

During the period of transition, your delivery may contain devices with and without the new symbols. The labelling meets all the applicable transition deadlines.

 

Latest Update 16th of September 2022