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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 44 of 44

Device	Model / Reference	Registries	Class	Status
Enterprise 5000x	E5X3FA013DFANA	EUDAMED	Class I	Active
AtmosAir Velaris	633031RO	EUDAMED	Class I	Active
Maxi Sky 2	MS025-B1-08	EUDAMED	Class I	Active
Alpha Active 3	648343W	EUDAMED	Class I	Active
Enterprise 5000x	E5X3OR118ACDFA	EUDAMED	Class I	Active
Auralis	636B02	EUDAMEDFDA UDI	Class I	Active
AtmosAir Velaris	633045LV	EUDAMED	Class I	Active
Sling - Paediatric clip sling	MAA4020M-XS	EUDAMEDFDA UDI	Class I	Active
AtmosAir Velaris	633043DE	EUDAMED	Class I	Active
Enterprise 9000x	9X21AJ021BBABA	EUDAMED	Class I	Active
Sling - Loop sling – padded legs	MLA2000-XS	EUDAMEDFDA UDI	Class I	Active
Enterprise 8000x	8X23GC113DBABA	EUDAMED	Class I	Active
Maxi Move	KMCSXE-99	EUDAMED	Class I	Active
Sling - Loop walking jacket	MAA5000-S	EUDAMEDFDA UDI	Class I	Active
Enterprise 9000x	9X22BK101FAAAA	EUDAMED	Class I	Active
AtmosAir Velaris	633029SL	EUDAMED	Class I	Active
Sonicaid	FCARE3SYS/12BED	EUDAMED	Class IIb	Active
Tornado	FA6M033011AIT1	EUDAMED	Class IIa	Active
Enterprise 9000x	9X22BG101BFABA	EUDAMED	Class I	Active
Maxi Move	KMCLAN-C-99	EUDAMED	Class I	Active
Nimbus	649AUT	EUDAMED	Class IIa	Active
Enterprise 5000x	E5X1AA011AAAAA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3QQ113DBDAA	EUDAMED	Class I	Active
Sonicaid	SC3SYS/40BED	EUDAMED	Class IIb	Active
Dopplex	DA100P	EUDAMEDFDA UDI	Class IIa	Active
Sonicaid	D920-P	EUDAMEDFDA UDI	Class IIa	Active
Maxi Sky 2 Plus	MS005-10-08	EUDAMED	Class I	Active
Maxi Move	KMCSAN-45	EUDAMED	Class I	Active
Sonicaid	ACC-OBS-008L	EUDAMED	Class I	Active
Enterprise 8000x	8X23HN003BDABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AD100AAAAA	EUDAMED	Class I	Active
Sling - Clip in situ sling – unpadded legs	MAA2040M-L	EUDAMEDFDA UDI	Class I	Active
Sling-Bariatric loop comfort	MAA8000-L	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X3QQ113BCAZA	EUDAMED	Class I	Active
Symbliss Bath Chair	SYBCS011-AT	EUDAMED	Class I	Active
Maxi Sky 2	MS115-01-10	EUDAMED	Class I	Active
AtmosAir Velaris	633017PL	EUDAMED	Class I	Active
Maxi Move 5	KMEHEA-M	EUDAMED	Class I	Active
AtmosAir Velaris	633020SL	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DR112CBDAA	EUDAMED	Class I	Active

Related Companies

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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