Certified Medical Devices

K-Tape and Crosstape are certified medical devices and comply with the requirements of MDR 2017/745

Entered into force on May 26, 2021, the new regulation replaces the previous directives and is now legally binding in all EU member states. Accordingly, all medical devices marketed or used within the European Union must be re-certified in accordance with this regulation.
Products that do not meet these requirements are prohibited from use in medical and therapeutic settings.

As a manufacturer, we have always placed great importance on ensuring that our K-Tape and Crosstape products comply with the applicable medical device regulations and directives. Beyond that, we are committed to combining the highest possible quality standards in both raw materials and manufacturing processes. This also applies to the implementation of MDR 2017/745.

Our K-Tape and Crosstape product lines meet the new requirements and are, of course, certified in accordance with the new regulations.

K-Tape and Crosstape are listed in the new European EUDAMED database and each product has the required UDI-DI – the Unique Device Identification – Device Identifier number. Instead of the familiar EAN scan code, you will now find the new UDI scan code on our packaging, which automatically includes the LOT number and expiration date.

For you as a medical institution, hospital, rehabilitation center, or clinic, this means that by using K-Tape and Crosstape, you are not only working with high-quality products, but also fully complying with the requirements of MDR 2017/745.

If you have any questions about our products, we will be happy to assist you.