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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 26 of 44

Device	Model / Reference	Registries	Class	Status
Enterprise 5000x	E5X1CE103BBABB	EUDAMED	Class I	Active
Maxi Sky 2	MS121-V1-98	EUDAMED	Class I	Active
AtmosAir Velaris	633024GR	EUDAMED	Class I	Active
Enterprise 8000x	8X23GA003BCAHB	EUDAMED	Class I	Active
Enterprise 5000x	E5X2PL003BBABA	EUDAMED	Class I	Active
Citadel Plus	FXX21A4B1AABBB	EUDAMED	Class I	Active
Maxi Move	KMCEAN-D-11	EUDAMED	Class I	Active
Maxi Sky 1000	LF21400-DK	EUDAMED	Class I	Active
Maxi Sky 440	LE00000-SE	EUDAMED	Class I	Active
Sling - Paediatric clip sling	MAA4020M0XS	EUDAMED	Class I	Active
Enterprise 9000x	9X22BG111DCCSA	EUDAMED	Class I	Active
Smartsigns	SC1200 12H	EUDAMED	Class IIb	Active
Pentaflex	150SL000/000W	EUDAMEDFDA UDI	Class I	Active
Sling - Clip sling – padded legs	MAA4000M-XXL	EUDAMEDFDA UDI	Class I	Active
AtmosAir Velaris	633042FR	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AJ000ABBOA	EUDAMED	Class I	Active
Sling - Paediatric clip sling	MAA4020M-XXS	EUDAMEDFDA UDI	Class I	Active
Sonicaid	TEAM3A N	EUDAMEDFDA UDI	Class IIb	Active
Maxi 500	KM560300-12	EUDAMED	Class I	Active
Sara Flex	HEB0000-10	EUDAMED	Class I	Active
Enterprise 5000x	E5X3BA006CCAZA	EUDAMED	Class I	Active
Flowtron	526000-03	EUDAMED	Class IIa	Active
Maxi Sky 2	MS016-02-10	EUDAMED	Class I	Active
AtmosAir Velaris	633025SK	EUDAMED	Class I	Active
Enterprise 5000x	E5X3HW103BCABA	EUDAMED	Class I	Active
Dopplex	ACC-VAS-008	EUDAMEDFDA UDI	Class I	Active
Citadel	CXX21A4G3AAAA0	EUDAMED	Class I	Active
Enterprise 5000x	E5X1BP111CDBNB	EUDAMED	Class I	Active
Maxi Sky 2	MS100-01-46	EUDAMED	Class I	Active
Enterprise 9000x	9X25H0101DCAEC	EUDAMED	Class I	Active
Enterprise 9000x	9X22HG111BCBOA	EUDAMED	Class I	Active
Arjo	ENT-ACC10	EUDAMED	Class I	Active
Enterprise 5000x	E5X2QG133BBBOA	EUDAMED	Class I	Active
Nimbus	649014NO	EUDAMED	Class IIa	Active
AtmosAir Velaris	633016SE	EUDAMED	Class I	Active
AtmosAir Velaris	633019IT	EUDAMED	Class I	Active
Citadel Plus	FXX21A4D4AABBB	EUDAMED	Class I	Active
AtmosAir Velaris	633044IT	EUDAMED	Class I	Active
Sara Combilizer	APA1000-SE	EUDAMED	Class I	Active
Sara Flex wipeable standing sling	TSS.503W	EUDAMEDFDA UDI	Class I	Active
Citadel Plus	FXX21A4C1ACFBB	EUDAMED	Class I	Active
Enterprise 5000x	E5X2QQ103BCAHB	EUDAMED	Class I	Active
Hydroven	5163L66	EUDAMEDFDA UDI	Class IIa	Active
Sling - Loop toilet sling – padded legs	MLA40310M	EUDAMED	Class I	Active
Evenda	EN91BGB5MLRAAZA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3AA009ABBOA	EUDAMED	Class I	Active
Sling - Loop bathing sling – unpadded legs	MLA4060-S	EUDAMEDFDA UDI	Class I	Active
Sling - Loop in situ sling – padded legs	MLAAS2000-S	EUDAMEDFDA UDI	Class I	Active
Enterprise 8000x	8X23GL003DCBOA	EUDAMED	Class I	Active
AtmosAir Velaris	633048IT	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