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 Certificate ACT Tempasure cardiac ablation catheter

CE Certificate cardiac ablation catheter system

CE Certificate sterilized custom packs for cardiovascular applications-CVC sets

CE Marking of Conformity Certificate Peripheral Embolic Protection Catheter

CE Certificate bone marrow collection system.

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 Certificate tubing set for liposuction procedure

CE Marking of Conformity Certificate vascular access devices for Hemodialysis

CAN/CSA ISO 13485:2003

Full compliance with 2007/47/EC