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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 38 of 44

Device	Model / Reference	Registries	Class	Status
Sonicaid	TEAM3A 3	EUDAMED	Class IIb	Active
Sling - Amputee clip toilet	MAA2091M0XL	EUDAMED	Class I	Active
Sling - Loop bathing sling – unpadded legs	MLA4060-M	EUDAMEDFDA UDI	Class I	Active
Enterprise 9000x	9X22BY111FFAZA	EUDAMED	Class I	Active
Sonicaid	SC3SW/30BED	EUDAMED	Class IIb	Active
Sling - Amputee loop hammock	MLA70000M	EUDAMEDFDA UDI	Class I	Active
Enterprise 8000x	8X23HG003BAABA	EUDAMED	Class I	Active
AtmosAir Velaris	633017PT	EUDAMED	Class I	Active
Evenda	EM92BFE7MLRAAFA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3PW133DCDBA	EUDAMED	Class I	Active
Enterprise 8000x	8X23HP113DEACA	EUDAMED	Class I	Active
Maxi Air	MAS000001-EU	EUDAMED	Class I	Active
Enterprise 8000x	8X23HR113BFACA	EUDAMED	Class I	Active
Maxi Move	KMCLXN-17	EUDAMED	Class I	Active
Maxi Sky 2	MS015-02-17	EUDAMED	Class I	Active
Sara Flex	HEB0000-11	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DE103BBAAB	EUDAMED	Class I	Active
AtmosAir Velaris	633049CY	EUDAMED	Class I	Active
Sling - Amputee clip	MAA2090M-XS	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCLAN-C-03	EUDAMED	Class I	Active
Enterprise 9000x	9X22FD111BBAKA	EUDAMED	Class I	Active
Alpha Active 4	648311UK	EUDAMED	Class IIa	Active
Enterprise 9000x	9X22BE101AFABA	EUDAMED	Class I	Active
AtmosAir Velaris	633044EN	EUDAMED	Class I	Active
Enterprise 8000x	8X23GH113BCAAA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3NQ006ACAZA	EUDAMED	Class I	Active
AtmosAir Velaris	633901SE	EUDAMED	Class I	Active
Sling-Bariatric loop	MAA8010-L	EUDAMEDFDA UDI	Class I	Active
Citadel	CXX22A4J1AAAC0	EUDAMED	Class I	Active
Enterprise 8000x	8X23G0103BEABA	EUDAMED	Class I	Active
Arjo	504029401	EUDAMED	Class I	Active
AtmosAir Velaris	633018SK	EUDAMED	Class I	Active
Maxi Sky 2	MS100-01-06	EUDAMED	Class I	Active
Enterprise 9000x	9X21AB101ADAAA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3AH007CBADB	EUDAMED	Class I	Active
Enterprise 8000x	8X24OY113DEAHB	EUDAMED	Class I	Active
Enterprise 5000x	E5X3DG006AFAJA	EUDAMED	Class I	Active
Maxi Sky 2	MS110-A2-08	EUDAMED	Class I	Active
Enterprise 9000x	9X21DJ111FBBVB	EUDAMED	Class I	Active
AtmosAir Velaris	633026PL	EUDAMED	Class I	Active
Enterprise 5000x	E5X3BG006ADABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3O4118CFDBA	EUDAMED	Class I	Active
Enterprise 8000x	8X24UG013DFDSA	EUDAMED	Class I	Active
Sling - Clip bathing sling – unpadded legs	MAA4060M-XXL	EUDAMEDFDA UDI	Class I	Active
Smartsigns	SC1500 5NP	EUDAMED	Class IIb	Active
Enterprise 5000x	E5X1AC101AAAJA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3BC006ABCHB	EUDAMED	Class I	Active
AtmosAir Velaris	633042RO	EUDAMED	Class I	Active
AtmosAir Velaris	633046SK	EUDAMED	Class I	Active
AtmosAir Velaris	633028CZ	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

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