Symbols Glossary

Compliance to global labeling regulations is a paramount priority. Our labeling follows global regulations including the Federal Drug Administration’s (FDA) General Device Labeling 21 CFR Part 801 and EU Medical Device Regulations (MDR) Article 23.1, Chapter III of Annexure I.

We use the following graphics, as required, to label our Medical Devices. These symbols are part of the ISO 15223-1:2021, EN 15986:2011, WEEE Directive 2012/19/EC, IEC 60601-1:2012 or MDR 2017/745 denoting the symbols and information to be provided on the labels of medical devices.

Authorized representative in the European Community - Alleset

Authorized representative in the European Community

ISO 15223-1:2021
Authorized Representative in Switzerland - Alleset

Authorized Representative in Switzerland

ISO 15223-1:2021
Batch code - Alleset

Batch code

ISO 15223-1:2021
Catalogue number - Alleset

Catalogue number

ISO 15223-1:2021
Caution - Alleset

Caution

ISO 15223-1:2021
CE Mark - Alleset

CE Mark

MDR 2017/745
CE 0123 Mark - Alleset

CE 0123 Mark

MDR 2017/745
Contains or presence of bis (2-ethylhexyl) phthalate (DEHP) - Alleset

Contains or presence of bis (2-ethylhexyl) phthalate (DEHP)

EN 15986:2011