22 July 2019
We are pleased to inform our customers that GenDx has been succesfully re-certified for ISO13485 and EC (IVD in Europe) by Tüv Süd per August 1 2019. Tüv Süd also replaces our former notified body Dekra, but this transfer has no impact on our products.
The only noticeable alteration is that for notified body CE marked products in Europe, the four digit code next to the CE symbol on the box and IFU will change. Starting August 1st, all notified body CE marked products will carry the Tüv Süd CE 0123 symbol.
During the official transfer period, till February 2020, we are still allowed to sell products produced before August 1st carrying the Dekra CE 0344 symbol.
You can download our renewed certificates below or from our website.
|ISO 13485 certificate||CE-IVD certificate|
Feel free to contact us if you have any questions!