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Certification

The market of medical products is very sensitive and fragile. Any uncontrolled action could lead to disastrous effects. All medical devices must undergo a conformity assessment procedure with European Union regulations.

In the case of electrostimulators and lasers, the manufacturer must be supervised by a Notified Body and receive a certificate confirming the product's compliance with EU regulations.

All our medical devices conform these requirements and the CE certificate was issued.


We were certified by TUV Rheinland

Please note that since 2017, the EU Regulation 2017/754 on medical devices have been in force - in simple terms, this regulation extend the validity of previous certificates until the end of 2028.
For this reason, although the certificate shows an expiration date of May 26, 2024, it remains valid by law until December 31, 2028.

 

  Please send all your questions and comments concerning our website to michal@kolmio.com.pl
(c) Copyright 1998-2023 KOLMIO KielkowscyVerified on: 05-06-2023
Last modified on: 14-07-2025
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