Getinge Disinfection AB

Address:LJUNGADALSGATAN 11,VAXJO Kronoberg,SE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Disinfector, Medical Devices (MEC) (7) Washer Of Body Waste Receptacles (FLH) (3)

Premarket Exempt

Yes

Clear

GETINGE 9100-SERIES - 07340153710054 Catalog Number : 9127E-001

Device Description : WASHER DISINFECTOR 9127E

Device Class : 2

Duns Number: 354023236

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

GETINGE 9100-SERIES - 07340153710061 Catalog Number : 9128E-001

Device Description : WASHER DISINFECTOR 9128E

Device Class : 2

Duns Number: 354023236

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

GETINGE 9100-SERIES - 07340153710078 Catalog Number : 9128EW-001

Device Description : WASHER DISINFECTOR 9128EW

Device Class : 2

Duns Number: 354023236

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

GETINGE 91-SERIES - 07340153710139 Catalog Number : 9122-002K960

Device Description : WASHER DISINFECTOR 9122 AWRFS. Customized 9122-002 equipped with Automatic Water WASHER DISINFECTOR 9122 AWRFS. Customized 9122-002 equipped with Automatic Water Rack Flush System (AWRFS).

Device Class : 2

Duns Number: 354023236

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

GETINGE 46-SERIES - 07340153710146 Catalog Number : 46-5-402K962

Device Description : WASHER DISINFECTOR 46-5 S+W D, S+W D indicating a single door washer disinfector WASHER DISINFECTOR 46-5 S+W D, S+W D indicating a single door washer disinfector with dryer. This is a customized version of 46-5-402 with water inlet through the roof plate and signal exchange for external valve for treated water.

Device Class : 2

Duns Number: 354023236

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

GETINGE CM320-SERIES - 07340153710153 Catalog Number : CM320WDK966

Device Description : CM320-2 CHAMBER WD, K966 is a customized variant of CM320WD with three water inl CM320-2 CHAMBER WD, K966 is a customized variant of CM320WD with three water inlet valves for cold water, hot water and for deionized water.

Device Class : 2

Duns Number: 354023236

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

GETINGE 46-SERIES - 07340153710160 Catalog Number : 46-4-402K968

Device Description : WASHER DISINFECTOR 46-4 S+W D, configured as 46-4-402 (DI 07340153700031) but wi WASHER DISINFECTOR 46-4 S+W D, configured as 46-4-402 (DI 07340153700031) but with alternate pump for distilled water.

Device Class : 2

Duns Number: 354023236

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

GETINGE 1600-SERIES - 07340153710191 Catalog Number : FD1600-001

Device Description : FLUSHER DISINFECTOR FD1600 NINJO. Flusher disinfector for human waste containers.

Device Class : 1

Duns Number: 354023236

Premarket Exempt : Yes

Product Code : FLH

Prescription Use : No

Device Count : 1

GETINGE 1800-SERIES - 07340153710207 Catalog Number : FD1800K902IP24

Device Description : FLUSHER DISINFECTOR FD1800 IP24 K902, with IP24 adaptation.

Device Class : 1

Duns Number: 354023236

Premarket Exempt : Yes

Product Code : FLH

Prescription Use : No

Device Count : 1

GETINGE 1800-SERIES - 07340153710214 Catalog Number : FD1810-001

Device Description : FLUSHER DISINFECTOR FD1810 TORNADO

Device Class : 1

Duns Number: 354023236

Premarket Exempt : Yes

Product Code : FLH

Prescription Use : No

Device Count : 1

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