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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 9 of 44

Device	Model / Reference	Registries	Class	Status
Maxi Sky 2	MS115-01-11	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DR112ABDAA	EUDAMED	Class I	Active
Maxi Sky 2	MS010-02-09	EUDAMED	Class I	Active
AtmosAir Velaris	633902PL	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AA001AECGB	EUDAMED	Class I	Active
Sling - Loop Walking Sling	TEM-M	EUDAMEDFDA UDI	Class I	Active
Citadel Plus	FXX21C4B3ABQBB	EUDAMED	Class I	Active
Enterprise 8000x	8X24HR113FFDAA	EUDAMED	Class I	Active
Maxi Twin	KTBB2FSX2WW	EUDAMEDFDA UDI	Class I	Active
Minuet 2	160AA2A1A	EUDAMED	Class I	Active
Maxi Move	KMCEAN-D-00	EUDAMED	Class I	Active
Sling-Bariatric loop hammock sling - divided legs	MAA80200M	EUDAMED	Class I	Active
Alenti	CDB8102-01	EUDAMED	Class I	Active
Enterprise 5000x	E5X1BM111ADABA	EUDAMED	Class I	Active
Kwiktrak	250-13031	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DY111ABACA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3FH003DBADB	EUDAMED	Class I	Active
Maxi 500	KM560380-EUUK	EUDAMED	Class I	Active
Arjo	504028902	EUDAMED	Class I	Active
Maxi Sky 2	MS005-02-15	EUDAMED	Class I	Active
Kwiktrak	200.12880	EUDAMED	Class I	Active
AtmosAir Velaris	633022EN	EUDAMED	Class I	Active
Arjo	ENT-ACC01	EUDAMED	Class I	Active
Enterprise 8000x	8X23HH113BCAAA	EUDAMED	Class I	Active
RIK Fluid Overlay	VL22000	EUDAMEDFDA UDI	Class I	Active
Maxi Sky 2	MS010-01-06	EUDAMED	Class I	Active
Enterprise 5000x	E5X1CA001ABBOA	EUDAMED	Class I	Active
Maxi Move 5	KMEHL0-M	EUDAMEDFDA UDI	Class I	Active
Sara Flex	HEB0000-08	EUDAMED	Class I	Active
Maxi Sky 2	MS100-02-15	EUDAMED	Class I	Active
Maxi Move	KMCLAN-C-16	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DE101CCADA	EUDAMED	Class I	Active
Maxi Move 5	KMESLA-M	EUDAMED	Class I	Active
Smartsigns	ACC-VSM-216	EUDAMED	Class I	Active
Maxi Sky 2	MS110-02-15	EUDAMED	Class I	Active
Enterprise 9000x	9X21BR111FEADA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1NX001AABNB	EUDAMED	Class I	Active
Enterprise 5000x	E5X1BB111CBDNA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3Q3003DFADA	EUDAMED	Class I	Active
AtmosAir Velaris	633028DK	EUDAMED	Class I	Active
Enterprise 5000x	E5X3QY003BFAZA	EUDAMED	Class I	Active
Enterprise 8000x	8X23GQ123BCAHB	EUDAMED	Class I	Active
Sonicaid	FD3-P	EUDAMEDFDA UDI	Class IIa	Active
Concerto	BAB2000-NL	EUDAMED	Class I	Active
Enterprise 5000x	E5G3Q4113BFAZA	EUDAMED	Class I	Active
Sonicaid	TEAM3A EB3	EUDAMED	Class IIb	Active
Sling - Loop sling – padded legs	MLA2000-L	EUDAMEDFDA UDI	Class I	Active
AtmosAir Velaris	633020PL	EUDAMED	Class I	Active
Enterprise 9000x	9X21AR111FDADA	EUDAMED	Class I	Active
Alpha Trancell Delux	ATD002DARW	EUDAMEDFDA UDI	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