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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 39 of 44

Device	Model / Reference	Registries	Class	Status
Maxi Move	KMCSXE-09	EUDAMED	Class I	Active
Enterprise 5000x	E5X3WQ000ABABA	EUDAMED	Class I	Active
Enterprise 9000x	9X21DG001DAABA	EUDAMED	Class I	Active
Citadel	CXX22C6M4AKCC0	EUDAMED	Class I	Active
Citadel Plus	FXX21C6B4AMBBA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3BA006AFANB	EUDAMED	Class I	Active
Maxi Sky 2	MS000-02-37	EUDAMED	Class I	Active
Sling - Loop toilet sling – padded legs	MLA40310L	EUDAMED	Class I	Active
Smartsigns	SC1500 12H	EUDAMED	Class IIb	Active
Enterprise 8000x	8X23GQ103BFBOA	EUDAMED	Class I	Active
Sling-Bariatric loop	MAA80100XL	EUDAMED	Class I	Active
Lifeguard	NLG55/EJ/1	EUDAMED	Class I	Active
Enterprise 5000x	E5X3DH116ACAJA	EUDAMED	Class I	Active
Auralis	636002RO	EUDAMED	Class IIa	Active
Maxi Sky 2	MS103-02-99	EUDAMED	Class I	Active
Sonicaid	TEAM3I M3	EUDAMED	Class IIb	Active
Enterprise 9000x	9X21EW111FFAIA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1BA101AACHB	EUDAMED	Class I	Active
Smartsigns	SC1500 5NIP	EUDAMED	Class IIb	Active
Enterprise 5000x	E5X1BA101ABAAA	EUDAMED	Class I	Active
Hydroven	5103A78	EUDAMEDFDA UDI	Class IIa	Active
Flowtron - DVT	DVT10	EUDAMED	Class I	Active
Enterprise 8000x	8X23HQ113BBDAA	EUDAMED	Class I	Active
Hydroven	510LI84	EUDAMEDFDA UDI	Class IIa	Active
Enterprise 9000x	9X22BG101BDABA	EUDAMED	Class I	Active
Maxi Sky 2 Plus	MS006-10-08	EUDAMED	Class I	Active
Citadel Plus	FXX21C4C4AANBB	EUDAMED	Class I	Active
Minstrel	HMA0001	EUDAMED	Class I	Active
Minuet 2	161AA8A1I	EUDAMED	Class I	Active
Smartsigns	SC1200 12N	EUDAMED	Class IIb	Active
Alpha Active 3	648305GR	EUDAMED	Class IIa	Active
Flowtron - DVT	L503-M	EUDAMED	Class I	Active
Enterprise 5000x	E5X3AC008ACBOA	EUDAMED	Class I	Active
Maxi Sky 2	MS000-01-40	EUDAMED	Class I	Active
Arjo	504029303	EUDAMED	Class I	Active
Dopplex	VP5XS	EUDAMED	Class IIa	Active
Maxi Sky 440	LE00000-GR	EUDAMED	Class I	Active
Sling - Paediatric clip sling	MAA4020M-S	EUDAMEDFDA UDI	Class I	Active
Sling-Bariatric loop hammock sling - divided legs	MAA8020-XXL	EUDAMEDFDA UDI	Class I	Active
Enterprise 8000x	8X23HR113DDDAA	EUDAMED	Class I	Active
Maxi Sky 2	MS125-L1-98	EUDAMED	Class I	Active
Enterprise 5000x	E5X3FB003BCAZA	EUDAMED	Class I	Active
AtmosAir Velaris	633022CY	EUDAMED	Class I	Active
Enterprise 5000x	E5X1BA101ABBOA	EUDAMED	Class I	Active
Sling - Loop Walking Sling	TEM-L	EUDAMED	Class I	Active
Sling - Clip bathing sling – padded legs	MAA4061M0LL	EUDAMEDFDA UDI	Class I	Active
Evenda	EM12BFE1BSPAAFA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1BQ001ABBNB	EUDAMED	Class I	Active
Enterprise 9000x	9X21AL001FBBOA	EUDAMED	Class I	Active
Enterprise 5000x	E5X2QG003BCAZA	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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