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Sources: EU EUDAMED, US FDA
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Getinge Disinfection AB
Manufacturer
🇸🇪 Sweden
GETINGE DISINFECTION AB
FDA registration
GETINGE DISINFECTION AB·2 products·🇸🇪 Sweden
Getinge Disinfection AB
Importer
🇸🇪 Sweden
Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
FDA Enforcement
Class II
·Terminated·Getinge Disinfection·October 23, 2013
Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI Info: 07340153700109, 07340153700116 Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading carriers (wash carts) from Getinge 86/88 series Washer-disinfectors. The automated loading/unloading systems in no way affect the cleaning/disinfection performance of the washer-disinfector. The automated loading/unloading equipment is considered an accessory to the medical washer-disinfector.
FDA Enforcement
Class II
·Terminated·Getinge Disinfection Ab·April 25, 2018
Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector 07340153700246, 07340153700253, 07340153700260, 07340153700277 Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading carriers (wash carts) from Getinge 86/88 series Washer-disinfectors. The automated loading/unloading systems in no way affect the cleaning/disinfection performance of the washer-disinfector. The automated loading/unloading equipment is considered an accessory to the medical washer-disinfector.
FDA Enforcement
Class II
·Terminated·Getinge Disinfection Ab·April 25, 2018
Washer Disinfector Aquadis 56; Model Number: 56A
FDA Enforcement
Class II
·Ongoing·Getinge Disinfection Ab·May 14, 2025
Washer Disinfector Aquadis 56; Model Number: 56M
FDA Enforcement
Class II
·Ongoing·Getinge Disinfection Ab·May 14, 2025
GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
FDA Enforcement
Class II
·Terminated·Getinge Disinfection Ab·December 31, 2014
Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
FDA Enforcement
Class III
·Terminated·Getinge Disinfection Ab·August 26, 2015
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
FDA Enforcement
Class II
·Ongoing·Getinge Disinfection Ab·October 8, 2025