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Arjohuntleigh AB

Sweden·SE-MF-000000696

Last updated September 17, 2026

Information

Country: Sweden
Address: Hans Michelsensgatan 10, Malmö, Sweden
Website: www.arjo.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +46 10 335 4500
PRRC Contact: Maria Fagerberg
EUDAMED SRN: SE-MF-000000696
FDA FEI Number: 3002806395
DUNS Number: 355804758

Catalogue (2190)

Page 6 of 44

Device	Model / Reference	Registries	Class	Status
Enterprise 5000x	E5X1AC101AAACA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1OA001ABBOA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3CZ116AEAZA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3QY103BFAZA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1BQ111ACACB	EUDAMED	Class I	Active
Sling - Clip in situ sling – unpadded legs	MAA2040M-S	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X1AC101AAABA	EUDAMED	Class I	Active
Conformx	150CX000/000W	EUDAMEDFDA UDI	Class I	Active
AtmosAir Velaris	633900SK	EUDAMED	Class I	Active
Enterprise 9000x	9X21CH111DFCSA	EUDAMED	Class I	Active
Enterprise 5000x	E5X2PL103BEABA	EUDAMED	Class I	Active
Sling - Clip sling – unpadded legs	MAA2000M-XS	EUDAMEDFDA UDI	Class I	Active
Sling - Loop Walking Sling	TEM-S	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AY000ABBOA	EUDAMED	Class I	Active
Citadel	CXX21A4R1ALQA0	EUDAMED	Class I	Active
Maxi Move	KMCSAE-16	EUDAMED	Class I	Active
Woundexpress	WE100GLXX	EUDAMED	Class IIa	Active
Sling - Clip in situ sling – unpadded legs	MAA2040M-M	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X30G003BFABA	EUDAMED	Class I	Active
Citadel Plus	FXX21A4B1AAJBA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DD111AAAAA	EUDAMED	Class I	Active
Enterprise 9000x	9X21CL111BCADA	EUDAMED	Class I	Active
AtmosAir Velaris	633047ES	EUDAMED	Class I	Active
Maxi Sky 2	MS005-01-17	EUDAMED	Class I	Active
Enterprise 8000x	8X23GL103BDAHA	EUDAMED	Class I	Active
Maxi Move 5	KMEHE0-0	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCLXN-C-03	EUDAMED	Class I	Active
Enterprise 9000x	9X21DR001DAABA	EUDAMED	Class I	Active
Enterprise 9000x	9X22BQ111AEABA	EUDAMED	Class I	Active
Sara Plus standing sling	KKA5120-L	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X1AD011ACBNA	EUDAMED	Class I	Active
Enterprise 9000x	9X21AA001FDAAB	EUDAMED	Class I	Active
Easytrack	9440030	EUDAMED	Class I	Active
Citadel Plus	FXX21C4A1AABBB	EUDAMED	Class I	Active
AtmosAir Velaris	633048SK	EUDAMED	Class I	Active
AtmosAir Velaris	633901ES	EUDAMED	Class I	Active
Enterprise 5000x	E5X1NM111ADABA	EUDAMED	Class I	Active
Sonicaid	US2-EUR	EUDAMED	Class I	Active
AtmosAir Velaris	633025DK	EUDAMED	Class I	Active
Enterprise 5000x	E5X1A101AAAAA	EUDAMED	Class I	Active
Enterprise 9000x	9X21AR101DDABA	EUDAMED	Class I	Active
Enterprise 9000x	9X21AY101BFABA	EUDAMED	Class I	Active
Enterprise 8000x	8X23GC123BCAHA	EUDAMED	Class I	Active
Maxi Move 5	KMEHS0-M	EUDAMEDFDA UDI	Class I	Active
Citadel Plus	FXX21A4A1AMFBB	EUDAMED	Class I	Active
Dopplex	ACC-VAS-011	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X1BG001AABOA	EUDAMED	Class I	Active
AtmosAir Velaris	633044PL	EUDAMED	Class I	Active
Enterprise 5000x	E5X1ND114CCAAA	EUDAMED	Class I	Active
Maxi Move	KMCSXN-C-17	EUDAMED	Class I	Active

Related Companies

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Authorities

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FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 11, 2013	Z-0926-2014	—	terminated	The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient
Aug 18, 2009	Z-2230-2009	—	terminated	A Scoop Stretcher is made up of two frames that are held together with two locking devices, one on each end. Each locking device contains a safety latch. The safety latch could unintentionally release when the side frames are pulled for positioning.
Jun 11, 2009	Z-1946-2009	—	terminated	Male patient genitals may be pinched between the seat and the frame of the patient lift chair when the Care Raiser seat is returned to its lowest position.
Apr 27, 2009	Z-1945-2009	—	terminated	The roll pin on certain configurations of the Maxilift hanger bar could break due to a combination of severe corrosion and fatigue. Breakage of the roll pin would lead to the detachment of the hanger bar from the jib of the lifter.
Feb 26, 2009	Z-1637-2009	—	terminated	If the sling clips are not applied or are applied incorrectly, there is the potential for the patient to fall, resulting in injury to both the patient and/or the caregiver.
Feb 26, 2009	Z-1636-2009	—	terminated	If the sling clips are not applied or are applied incorrectly, there is the potential for the patient to fall, resulting in injury to both the patient and/or the caregiver.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Arjohuntleigh, Inc. US