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
02-699 Warszawa
+48 (22) 46 45 200
Quality Management System
European Authorized Representatives
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
(+49)-511-6262 8630
www.mdss.com
MediMark Europe
11, rue Emile Xola – BP 2332
38033 Grenoble Cedex 2, France
+33 (0)4 76 86 43 22
www.medimark-europe.com
Product Certifications and Approvals
Europe
Stretta and RF Generator Certificate
Dx-pH Measurement System Certificate