Certificate No. 60100016

Certificate Number: 60100016
Certificate Holder: PROTRANS medizinische diagnostische
Produkte GmbH
Ketschau 2
68766 Hockenheim
Germany
Scope:

Design and development, production and distribution of
HLA-typing reagents

Fulfilled Standards: EN ISO 13485:2012
EN ISO 13485:2012/AC:2012
Certificate Type: QMS

Quality Management System, Standard Conformity
EN ISO13485 quality management standard for medical devices and related services

The certification body hereby certifies that the organization has established and maintains a quality management system according to EN ISO 13485. The quality management system of the organization is subject to a yearly surveillance audit.