FDA

Device Listing/Establishment Registration

US FDA Good Manufacturing Practice (GMP)
Restech is compliant with 21 CFR Part 820, US FDA Quality Systems Regulations


Notified Body

Polish Center for Testing and Certification
ul. Kłobucka 23A
02-699 Warszawa
+48 (22) 46 45 200

Quality Management System

ISO 13485: 2016

European Authorized Representatives

MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
(+49)-511-6262 8630
www.mdss.com 


Product Certifications and Approvals

Europe

Stretta + Secca Certificate

Dx-pH Measurement System Certificate

 

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