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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 23 of 44

Device	Model / Reference	Registries	Class	Status
Maxi Sky 2	MS120-A1-08	EUDAMED	Class I	Active
AtmosAir Velaris	633049EN	EUDAMED	Class I	Active
Enterprise 8000x	8X23GE103BFADA	EUDAMED	Class I	Active
Kwiktrak	200-12888	EUDAMED	Class I	Active
Maxi 500	KM560080	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCSXN-D-99	EUDAMED	Class I	Active
AtmosAir Velaris	633029GR	EUDAMED	Class I	Active
Citadel	CXX21A4Q2ABRA0	EUDAMED	Class I	Active
Arjo	ENT-ACC40	EUDAMED	Class I	Active
Kwiktrak	200-13020	EUDAMED	Class I	Active
Citadel Plus	FXX21A4C4AKJBB	EUDAMED	Class I	Active
Maxi Sky 2	MS003-01-08	EUDAMED	Class I	Active
AtmosAir Velaris	633023DK	EUDAMED	Class I	Active
Maxi Sky 2	MS010-01-09	EUDAMED	Class I	Active
Nimbus	649012	EUDAMED	Class IIa	Active
Enterprise 5000x	E5X3BE006ADBOA	EUDAMED	Class I	Active
Hydroven	316A68	EUDAMEDFDA UDI	Class IIa	Active
Maxi Move	KMCLXN-D-07	EUDAMED	Class I	Active
Enterprise 5000x	E5G1DG101AAAAA	EUDAMED	Class I	Active
Symbliss Bath Chair	SYBCS001-BE	EUDAMED	Class I	Active
Enterprise 8000x	8X23GC113DCAAA	EUDAMED	Class I	Active
Enterprise 9000x	9X22GQ131FFADB	EUDAMED	Class I	Active
Evenda	EN81ANB2SLQAAZA	EUDAMED	Class I	Active
Enterprise 5000x	E5X2EA113BBBOA	EUDAMED	Class I	Active
Enterprise 9000x	9X22BG111BFBNB	EUDAMED	Class I	Active
Sling-Bariatric loop comfort	MAA8000-M	EUDAMEDFDA UDI	Class I	Active
Sling - Loop toilet sling – padded legs	MAA4031M-L	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X3EA003BBBOA	EUDAMED	Class I	Active
Maxi Move	KMCEAN-03	EUDAMED	Class I	Active
Sling - Loop toilet sling – padded legs	MAA4031M-LL	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X3QQ113BFAZA	EUDAMED	Class I	Active
Maxi Move	KMCLXN-D-10	EUDAMED	Class I	Active
Enterprise 8000x	8X23GY113BCABA	EUDAMED	Class I	Active
Maxi Sky 2	MS010-A2-06	EUDAMED	Class I	Active
Alpha Active 3	648305	EUDAMED	Class IIa	Active
Enterprise 8000x	8X23TL133BBAHB	EUDAMED	Class I	Active
Dopplex	ACC-VAS-025	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X1BA001ACAHB	EUDAMED	Class I	Active
Maxi Move	KMCSXE-11	EUDAMED	Class I	Active
Sonicaid	TEAM3A NM3	EUDAMED	Class IIb	Active
Enterprise 5000x	E5X1BQ011ABDJB	EUDAMED	Class I	Active
Sling - Amputee clip sling - “hook & loop" fastener	MAA4040M-L	EUDAMEDFDA UDI	Class I	Active
Enterprise 9000x	9X21CR111FFAZA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3PS003BDABA	EUDAMED	Class I	Active
Sara Flex wipeable standing sling	TSS.500W	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCSXE-C-03	EUDAMED	Class I	Active
Enterprise 5000x	E5X1BC111ACAZA	EUDAMED	Class I	Active
Sling - Amputee clip bathing in situ	MAA2080M-M	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X3PG103BEABA	EUDAMED	Class I	Active
Maxi Sky 2	MS016-01-08	EUDAMED	Class I	Active

Related Companies

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Notified Bodies

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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