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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 33 of 44

Device	Model / Reference	Registries	Class	Status
Enterprise 8000x	8X23O2103BEADA	EUDAMED	Class I	Active
Walker	GCB4101-031	EUDAMED	Class I	Active
AtmosAir Velaris	633049FR	EUDAMED	Class I	Active
Sling - Clip bathing sling – unpadded legs	MAA4060M-M	EUDAMEDFDA UDI	Class I	Active
Sling - Amputee clip bathing in situ	MAA2080M-L	EUDAMEDFDA UDI	Class I	Active
Maxi Sky 2	MS111-V1-08	EUDAMED	Class I	Active
Enterprise 9000x	9X22CG101BDABA	EUDAMED	Class I	Active
Maxi Move	KMCSXE-C-15	EUDAMED	Class I	Active
Citadel	CX721B6R4AMFA0	EUDAMED	Class I	Active
Alpha Active 4	648315SI	EUDAMED	Class IIa	Active
Enterprise 5000x	E5X1NA002AFAJA	EUDAMED	Class I	Active
Enterprise 8000x	8X24UG033DCDSA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3OQ006AEABA	EUDAMED	Class I	Active
Enterprise 9000x	9X21AG001FAAZA	EUDAMED	Class I	Active
AtmosAir Velaris	633029PL	EUDAMED	Class I	Active
Sara Plus standing sling – extra postural support	KKA5370-M	EUDAMEDFDA UDI	Class I	Active
Easytrack	9220110	EUDAMED	Class I	Active
Bolero	CEB6022-01	EUDAMED	Class I	Active
Enterprise 8000x	8X23HG113BFACA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AQ000ABBOA	EUDAMED	Class I	Active
Maxi Move	KMCSAN-C-UK	EUDAMED	Class I	Active
Enterprise 5000x	E5X3PG103BCABA	EUDAMED	Class I	Active
Hydroven	5101A78	EUDAMEDFDA UDI	Class IIa	Active
Lifeguard	NLG20/C5/TR/1	EUDAMED	Class I	Active
AtmosAir Velaris	633044LV	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DD101AAAZA	EUDAMED	Class I	Active
Sling - Amputee clip	MAA2090M0XL	EUDAMED	Class I	Active
Enterprise 8000x	8X23HJ113BABOA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1BC101ABDDB	EUDAMED	Class I	Active
Minuet 2	161AC8A1G	EUDAMED	Class I	Active
Maxi Move	KMCSXE-12	EUDAMED	Class I	Active
Enterprise 5000x	E5X3EH003BDABA	EUDAMED	Class I	Active
Maxi Move	KMCLAN-D-05	EUDAMED	Class I	Active
Enterprise 9000x	9X22BG111DCAAB	EUDAMED	Class I	Active
Enterprise 9000x	9X21DL101FCCTB	EUDAMED	Class I	Active
Enterprise 5000x	E5X3B1006ACAZA	EUDAMED	Class I	Active
Maxi Sky 2	MS103-01-99	EUDAMED	Class I	Active
Enterprise 5000x	E5X3YQ138CFBNA	EUDAMED	Class I	Active
Enterprise 9000x	9X22BB101AAAAA	EUDAMED	Class I	Active
AtmosAir Velaris	633043CZ	EUDAMED	Class I	Active
Maxi Move	KMCSAE-12	EUDAMED	Class I	Active
Minuet 2	160AC5B2F	EUDAMED	Class I	Active
Enterprise 5000x	E5X3QN113DFDBA	EUDAMED	Class I	Active
Maxi Move	KMCEAN-09	EUDAMED	Class I	Active
Citadel	CXX21C6W4AAKB0	EUDAMED	Class I	Active
Evenda	EN51AYB5MLNABDA	EUDAMED	Class I	Active
Sling - Loop walking jacket	MAA50000L	EUDAMED	Class I	Active
Enterprise 9000x	9X21AA101FAAKB	EUDAMED	Class I	Active
Sling - Amputee clip toilet	MAA2091M-M	EUDAMEDFDA UDI	Class I	Active
Sling - Bariatric loop hammock	MAA8030-M	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

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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