Our new labels

2D code: easier device identification – automatic data scanning

We are already 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.

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

Examples of UDI codes:

 
UDI Code - Example 1
 
UDI Code - Example 2

 

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 - Recognize 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

 

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

 

Examples of different labels:

Label – Example 1
 Label – Example 2

 

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.