MDR certification process completed
10.02.2024QM System certification according to EU 2017/742/IX/I+III
MDC medical device certification GmbH. has certified that SY-LAB has implemented and applies a quality management system in accordance with Annex IX, Chapter I and III of regulation (EU) 2017/745 for conformity assessment of the computer controlled freezers - IceCube 11 XS, 14S, 14M, 17M, 17L.
SY-LAB now is allowed to manufcature and distribute the whole computer controlled freezer range as medical decive of risk class IIa for the following purpose:
Gentle cooling of blood, blood components, organs,and organ parts, cells, tissue, and other body fluids in appropriate containers (ampoules, bags or straws) under controlled and reproducible conditions for the purpose of cryo storage, subsequent thawing and perfusion, administration, or intriduction into the human body.