ISO / EN Certification
CMI is ISO 13485:2003 certified using Kema Quality BV, Arnhem, The Netherlands as our Notified Body.

Download ISO/EN certificate

Download ISO/EN Addendum

FDA Registration
CMI’s Dresden, Germany and Hradec Králové, Czech Republic facilities are FDA registered and comply with the US FDA’s GMP Guidelines

CE Marking of Conformity Certificate Custom Packs

EC Design- Examination Certificate Central Venous Catherization Set

CE Marking of Conformity Certificate Peripheral Embolic Protection Catheter

CE Marking of Conformity Certificate Steril-Endo-Bronchial-Blocking-Device-for-Airway-Management

CE-Marking-of-Conformity-Certificate-Introducer-Sheath-System-for-percutaneous-intravascular-Introduction

CE Marking of Conformity Certificate Vascular-Access-Devices-for-Hemodialysis

CAN/CSA ISO 13485:2003

Full compliance with 2007/47/EC