TÜV SÜD is temporarily suspending Getinge’s CE certificate for Cardiosave
The notified body, TÜV SÜD, is temporarily suspending the CE certificate for Getinge’s Cardiosave Intra-Aortic Balloon Pump with immediate effect. Getinge is given six months to adhere to the required corrective actions. The financial impact is not expected to be material for Getinge.As previously communicated by Getinge, the CE certificate for Getinge’s subsidiary Datascope Corp. for the Cardiosave Intra-Aortic Balloon Pump, was reinstated by TÜV SÜD in July 2023 after approximately three months of suspension due to gaps identified in compliance with applicable regulation. This decision