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
02-699 Warszawa
Quality Management System
European Authorized Representatives
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
(+49)-511-6262 8630
www.mdss.com
Product Certifications and Approvals
Europe
Stretta, Secca, and RF Generator Certificate
Dx-pH Measurement System Certificate