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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 16 of 44

Device	Model / Reference	Registries	Class	Status
AtmosAir Velaris	633017HU	EUDAMED	Class I	Active
Sonicaid	8400-6920L	EUDAMED	Class I	Active
Smartsigns	SC1200 5N	EUDAMED	Class IIb	Active
AtmosAir Velaris	633018SL	EUDAMED	Class I	Active
AtmosAir Velaris	633043SE	EUDAMED	Class I	Active
Enterprise 5000x	E5X3DG016ACBOA	EUDAMED	Class I	Active
Sonicaid	TEAM3A M3	EUDAMED	Class IIb	Active
Enterprise 5000x	E5X1DM111AAABA	EUDAMED	Class I	Active
Enterprise 8000x	8X23HN103BDABB	EUDAMED	Class I	Active
Maxi Sky 2	MS100-02-40	EUDAMED	Class I	Active
AtmosAir Velaris	633046SL	EUDAMED	Class I	Active
Maxi Move	KMCSAE-C-99	EUDAMED	Class I	Active
Alpha Active 4	648334	EUDAMED	Class I	Active
AtmosAir Velaris	633019DK	EUDAMED	Class I	Active
Maxi Move	KMCLAN-D-17	EUDAMED	Class I	Active
AtmosAir Velaris	633028IT	EUDAMED	Class I	Active
Enterprise 5000x	E5X2QQ103BCABA	EUDAMED	Class I	Active
Dopplex	ACC-VAS-024	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCSXN-37	EUDAMED	Class I	Active
Minuet 2	161AC8A1IT	EUDAMED	Class I	Active
Maxi Move	KMCSAE-D-06	EUDAMED	Class I	Active
AtmosAir Velaris	633021DE	EUDAMED	Class I	Active
Maxi Move	KMCSAE-D-11	EUDAMED	Class I	Active
Maxi Sky 2	MS035-01-08	EUDAMED	Class I	Active
Enterprise 5000x	E5X1FC101AAABA	EUDAMED	Class I	Active
Maxi Move	KMCSXE-17	EUDAMED	Class I	Active
Lymphassist	316EURHC	EUDAMEDFDA UDI	Class IIa	Active
AtmosAir Velaris	633028DE	EUDAMED	Class I	Active
Sonicaid	D930-P	EUDAMEDFDA UDI	Class IIa	Active
Maxi Move	KMCSAE-C-10	EUDAMED	Class I	Active
Maxi Sky 2	MS010-01-40	EUDAMED	Class I	Active
Enterprise 9000x	9X24BE101FCAAA	EUDAMED	Class I	Active
Maxi Move	KMCLXN-C-16	EUDAMED	Class I	Active
Smartsigns	SC1500 12HP	EUDAMED	Class IIb	Active
Nimbus 4	650001P	EUDAMED	Class I	Active
Enterprise 9000x	9X22CY111BBBOA	EUDAMED	Class I	Active
Smartsigns	SC500 HE	EUDAMED	Class IIb	Active
Maxi Move	KMCSXN-25	EUDAMED	Class I	Active
Enterprise 9000x	9X21AA001BBB0A	EUDAMED	Class I	Active
Enterprise 5000x	E5X2PB003DBADA	EUDAMED	Class I	Active
Sling - Amputee loop hammock	MLA7000A-L	EUDAMEDFDA UDI	Class I	Active
Enterprise 8000x	8X23GC103BCABB	EUDAMED	Class I	Active
AtmosAir Velaris	633028CY	EUDAMED	Class I	Active
Sling - Bariatric loop hammock	MAA8030-XXL	EUDAMEDFDA UDI	Class I	Active
Smartsigns	SC1200 5HP	EUDAMED	Class IIb	Active
Enterprise 5000x	E5X3P3123BFDAA	EUDAMED	Class I	Active
Sling - Loop toilet sling – padded legs	MLA4031-M	EUDAMEDFDA UDI	Class I	Active
Sling - Clip bathing in situ sling – unpadded legs	MAA2070M0S	EUDAMED	Class I	Active
Lifeguard	LGMAT/13	EUDAMED	Class I	Active
Hydroven	510004ES	EUDAMED	Class IIa	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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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