EC Certificate - Production Quality Assurance

In respect of:
The manufacture of sterile use vascular access catheters, heart cooling jackets, extracorporeal blood circuits and blood tubing connectors.

Certificate of Registration

Holds Certificate No: FM 591879
and operates a Quality Management System which complies woth the requirements of ISO 13485:2003 for the following scope:

Design, manufacture, sterilization and distribution of Perfusion and Critical Care Assemblies.