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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 34 of 44

Device	Model / Reference	Registries	Class	Status
Sling - Loop bathing sling – unpadded legs	MLA40600M	EUDAMED	Class I	Active
Sara Flex wipeable standing sling	TSS.501W	EUDAMEDFDA UDI	Class I	Active
Sling - Loop toilet sling – padded legs, without head support	MLA45310M	EUDAMED	Class I	Active
Nimbus	649017	EUDAMED	Class IIa	Active
Sonicaid	SC3/ANALYSIS	EUDAMED	Class IIb	Active
Lifeguard	NLG55/EN/1	EUDAMED	Class I	Active
Enterprise 9000x	9X22BQ011BBBOA	EUDAMED	Class I	Active
Enterprise 8000x	8X23HG113BFAJA	EUDAMED	Class I	Active
Maxi Air	MAS000001-DK	EUDAMED	Class I	Active
Maxi Sky 2	MS113-01-03	EUDAMED	Class I	Active
Maxi Move	KMCSXN-D-08	EUDAMED	Class I	Active
Pentaflex	150SL000/000P	EUDAMEDFDA UDI	Class I	Active
Arjo	ENT-ACC26	EUDAMED	Class I	Active
Alpha Active 3	648325W	EUDAMED	Class I	Active
Sling - Loop toilet sling – padded legs	MAA4031M0S	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DQ111ABACA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DD101ACAAB	EUDAMED	Class I	Active
Enterprise 5000x	E5X3OZ116CADBA	EUDAMED	Class I	Active
Maxi Sky 2	MS110-02-17	EUDAMED	Class I	Active
Enterprise 8000x	8X23HR113FBDAA	EUDAMED	Class I	Active
AtmosAir Velaris	633042NO	EUDAMED	Class I	Active
Enterprise 5000x	E5X3OZ116CFDBA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3NC106CAABA	EUDAMED	Class I	Active
Enterprise 9000x	9X22CL101BDABA	EUDAMED	Class I	Active
Citadel Plus	FXX21C6C4AKZBB	EUDAMED	Class I	Active
Enterprise 9000x	9X22BE111BDAAA	EUDAMED	Class I	Active
Enterprise 5000x	E5X2QG113BBGRA	EUDAMED	Class I	Active
Enterprise 9000x	9X22BQ111FFAIB	EUDAMED	Class I	Active
Sling - Clip bathing in situ sling – unpadded legs	MAA2070M-S	EUDAMEDFDA UDI	Class I	Active
Citadel Plus	FXX21C4B1AKAAB	EUDAMED	Class I	Active
Sara Plus	HEP0001	EUDAMED	Class I	Active
Sling - Loop bathing sling – unpadded legs	MLA4060-L	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X3PC003BMABA	EUDAMED	Class I	Active
Minuet 2	160AA1A1A	EUDAMED	Class I	Active
Maxi 500	KM560380-08	EUDAMED	Class I	Active
Enterprise 5000x	E5X3DR117CCDAA	EUDAMED	Class I	Active
Sonicaid	SC3SYS/CLNT	EUDAMED	Class IIb	Active
Minuet 2	160AC6A1G	EUDAMED	Class I	Active
Enterprise 5000x	E5X3FL00ABDBOA	EUDAMED	Class I	Active
Arjo	504029403	EUDAMED	Class I	Active
Enterprise 5000x	E5X3AC006AEBOA	EUDAMED	Class I	Active
Sara Flex	HEB2100-08	EUDAMED	Class I	Active
Dopplex	ACC-VAS-016	EUDAMEDFDA UDI	Class I	Active
AtmosAir Velaris	633030LV	EUDAMED	Class I	Active
Enterprise 5000x	E5X2EN003BBBOA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3QQ103BEABA	EUDAMED	Class I	Active
Maxi Sky 2	MS105-02-16	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AA101ACAAA	EUDAMED	Class I	Active
Sonicaid	TEAM3A MB3	EUDAMED	Class IIb	Active
AtmosAir Velaris	633016FR	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

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Importers

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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