Regulatory

We are now fully transitioned to AR EXPERTS B.V. as our EU|REP for all products. We have made IFU and labeling changes for SLS, changes are complete for Virtua, Horizon and Media.

The transition from EU|REP CEPartner4U to AR Experts B.V.(part of the Kader Group, based in the Netherlands) is complete after acquisition. Please note the change as it affects to product labeling, IFU, and EUDAMED listings. Continuity of all services and support in compliance with Medical Device Regulation (EU) 2017/745, Restriction of the use of certain hazardous substances (RoHS)/Registration 2011/65/EU and 2015/863/EU, Evaluation, and Authorization of Chemicals (REACH) 1907/2006/EU, ISO 13485:2016/NS-EN ISO 13485:2016 245216-2017-AQ-USA-NA-PS Rev. 1.0, and IEC 60601-1-2:2014 4th Edition (EU) 2017/745 is assured.

Support Documentation

MDR Multi-language IFU

ISO / EU-DOC / FDA-CFG / RoHS REACH

Please select the appropriate document from the links below:

ISO 13485:2016
RoHS/REACH Declaration
EU DOC
EU DOC Declaration
FDA-CFG
FDA-CFG Addendum
Codonics | Innovator of the Safe Label System®
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