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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 42 of 44

Device	Model / Reference	Registries	Class	Status
Maxi Move	KMCEXN-D-99	EUDAMED	Class I	Active
Sling-Bariatric loop comfort	MAA8000A0L	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X2QC103DCAAA	EUDAMED	Class I	Active
Citadel Plus	FXX21C4A4AKBBB	EUDAMED	Class I	Active
Maxi Sky 2	MS100-02-46	EUDAMED	Class I	Active
Enterprise 8000x	8X23V5133DFADA	EUDAMED	Class I	Active
Sling-Bariatric loop hammock sling - divided legs	MAA8020-L	EUDAMEDFDA UDI	Class I	Active
Maxi Sky 2	MS000-02-15	EUDAMED	Class I	Active
Maxi Move	KMCSAN-C-05	EUDAMED	Class I	Active
Citadel	CXX22C4J1AAAD0	EUDAMED	Class I	Active
Sling - Loop toilet sling – padded legs, without head support	MLA4531-XL	EUDAMEDFDA UDI	Class I	Active
Sling - Amputee clip	MAA2090M0XS	EUDAMED	Class I	Active
Alpha Active 4	648326W	EUDAMED	Class I	Active
Carendo	BIB2005-01	EUDAMED	Class I	Active
Enterprise 5000x	E5X1BQ001ABDJB	EUDAMED	Class I	Active
Hydroven	5163L71	EUDAMEDFDA UDI	Class IIa	Active
Sling - Clip sling – unpadded legs	MAA2000M-LL	EUDAMEDFDA UDI	Class I	Active
Arjo	ENT-ACC05	EUDAMED	Class I	Active
Nimbus	649014HU	EUDAMED	Class IIa	Active
Maxi 500	KM560380-17	EUDAMED	Class I	Active
Maxi Move 5	KMESSA-M	EUDAMED	Class I	Active
Maxi Sky 2	MS116-01-06	EUDAMED	Class I	Active
Maxi Air	MAS000001-UK	EUDAMED	Class I	Active
Enterprise 9000x	9X22BG111BEBOA	EUDAMED	Class I	Active
System 2000 - Primo	AP32211GB2101	EUDAMED	Class I	Active
Enterprise 8000x	8X23HJ113BBBOA	EUDAMED	Class I	Active
AtmosAir Velaris	633042CY	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DC101ABAAA	EUDAMED	Class I	Active
Maxi 500	KM560380-56	EUDAMED	Class I	Active
Symbliss Bath Chair	SYBCS001-DE	EUDAMED	Class I	Active
Sara Flex standing sling	TSS.502	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCSAN-D-15	EUDAMED	Class I	Active
Symbliss Bath Chair	SYBCS001-FR	EUDAMED	Class I	Active
Maxi Move	KMCEXN-D-12	EUDAMED	Class I	Active
Enterprise 5000x	E5X2F0003BBBOA	EUDAMED	Class I	Active
Maxi Sky 2	MS006-02-08	EUDAMED	Class I	Active
Maxi Sky 2 Plus	MS005-10-10	EUDAMED	Class I	Active
Enterprise 9000x	9X22BW111BEABB	EUDAMED	Class I	Active
Maxi Move	KMCEAN-D-17	EUDAMED	Class I	Active
Maxi Move	KMCSAN-D-05	EUDAMED	Class I	Active
Maxi Sky 440 Portable	AHLE00000-ES	EUDAMED	Class I	Active
Enterprise 8000x	8X23GA103BBABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3AA007ABBOA	EUDAMED	Class I	Active
Sling - Loop Walking Sling	TEM-S	EUDAMEDFDA UDI	Class I	Active
Concerto	BAB1007-01	EUDAMED	Class I	Active
Maxi Sky 2	MS100-02-45	EUDAMED	Class I	Active
Sling - Amputee clip	MAA2090M0LL	EUDAMED	Class I	Active
Enterprise 9000x	9X22BR111FEADA	EUDAMED	Class I	Active
Enterprise 8000x	8X24GM103BFAHB	EUDAMED	Class I	Active
Maxi Move	KMCLAN-11	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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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