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PRODUCT CERTIFICATIONS

 

EB Neuro provides high quality standards as required by the intended use of our products and the presence in the countries with the strictest regulations. These activities require a complete commitment in order to achieve and maintain product certifications, to monitor internal processes and product proper documentation.

 

EB Neuro complies with the following certifications:

UNI EN ISO 9001 / ISO 9001:2015
EN 46001 ISO 13485:2016
QSR 21 CFR Part 820 Federal Law

ISO 9001:2015

ISO 13485:2016

(93/42/EEC)

(93/42/EEC)
 
All products are CE-Marked and several items are also FDA-cleared and certified by CSA. Most products have also been registered with other national standards (Korean KFDA, Taiwan TFDA, Chinese SFDA, Brasil Anvisa, etc.).

 

Published certificates: