Certifications &
Notifications
ISO 13485:2016 Certificate (Cincinnati)
MDSAP Certificate (Cincinnati)
CE Marking Certificate of Conformity (Cincinnati)
Certificate of Foreign Government (Cincinnati)
Health Canada Certificates (Cincinnati)
Certificate for Quality Management EN ISO 13485:2016 + AC:2018 + A11:2021 (Cincinnati)
Notified Body Confirmation Letter on the extension of MDD Certificates 50192-16-06 and 50192-17-08 (Stihler)
URGENT Medical Device Recall Electri-Cool II Cooling System
Latex Declaration
Hemotherm CE Dual Reservoir Cooler-Heater Communications
ECMO-Heater & Hemotherm MR 115V End-of-Life Notification
HemoMR NOT111W - End of Life
URGENT Medical Device Recall Hemotherm CE Dual Reservoir Cooler/Heater Model 400CE 115V
Hemotherm 400CE Technical and Operation Manual English 58418-Z
Hemotherm 400CE Operation Manual English 56075-L
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