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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 29 of 44

Device	Model / Reference	Registries	Class	Status
Citadel Plus	FXX21C4C2AABBB	EUDAMED	Class I	Active
Enterprise 5000x	E5X3AA000CCADA	EUDAMED	Class I	Active
AtmosAir Velaris	633021IT	EUDAMED	Class I	Active
Enterprise 9000x	9X21AB101AAAAA	EUDAMED	Class I	Active
Enterprise 9000x	9X22CY111FCBOA	EUDAMED	Class I	Active
Citadel Plus	FXX21A4D3AMFBB	EUDAMED	Class I	Active
AtmosAir Velaris	633027NL	EUDAMED	Class I	Active
Dopplex	DMXRABI	EUDAMED	Class IIa	Active
Enterprise 5000x	E5X2PQ113BBDJB	EUDAMED	Class I	Active
Citadel Plus	FXX21A4B2AABBB	EUDAMED	Class I	Active
AtmosAir Velaris	633025SL	EUDAMED	Class I	Active
Enterprise 8000x	8X23HC103BBBOA	EUDAMED	Class I	Active
Enterprise 8000x	8X23PQ103BEBOA	EUDAMED	Class I	Active
Caylis	675801	EUDAMED	Class I	Active
Hydroven	316TIS	EUDAMED	Class IIa	Active
AtmosAir Velaris	633900PT	EUDAMED	Class I	Active
Sling - Loop sling – padded legs	MLA2000A0M	EUDAMED	Class I	Active
Enterprise 8000x	8X23HQ003BDABA	EUDAMED	Class I	Active
AtmosAir Velaris	633023GR	EUDAMED	Class I	Active
Enterprise 5000x	E5X3Q5103BFAZA	EUDAMED	Class I	Active
Enterprise 5000x	E5X2PC113DAABA	EUDAMED	Class I	Active
Maxi Move	KMCSXN-36	EUDAMED	Class I	Active
Dopplex	PA8-HG	EUDAMEDFDA UDI	Class I	Active
Sara Plus standing sling	KKA5120-XL	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X1DH101CAAAA	EUDAMED	Class I	Active
Flowtron - Tri Pulse	TRP30	EUDAMED	Class I	Active
Nimbus 4	650201P	EUDAMED	Class I	Active
AtmosAir Velaris	633045SE	EUDAMED	Class I	Active
Maxi Sky 2	MS110-A2-06	EUDAMED	Class I	Active
AtmosAir Velaris	633049NO	EUDAMED	Class I	Active
Enterprise 8000x	8X23GD103DAAAA	EUDAMED	Class I	Active
Sling - Loop walking jacket	MAA5000-M	EUDAMEDFDA UDI	Class I	Active
Maxi 500	KM560380-12	EUDAMED	Class I	Active
AtmosAir Velaris	633049HU	EUDAMED	Class I	Active
Pentaflex	150SL000/000	EUDAMEDFDA UDI	Class I	Active
Maxi Sky 440	LE00000-CZ	EUDAMED	Class I	Active
Enterprise 5000x	E5X3BC106CCABA	EUDAMED	Class I	Active
Enterprise 9000x	9X22BG001BFBOA	EUDAMED	Class I	Active
Enterprise 5000x	E5X2QR113DEDAA	EUDAMED	Class I	Active
AtmosAir Velaris	633030PL	EUDAMED	Class I	Active
Sonicaid	FD1-P-EUR	EUDAMEDFDA UDI	Class IIa	Active
Maxi Sky 2	MS011-L2-98	EUDAMED	Class I	Active
Enterprise 8000x	8X23GA003BAABA	EUDAMED	Class I	Active
Concerto	BAB1107-01	EUDAMED	Class I	Active
Lifeguard	NLG20/5/EI/2	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DA101AAACA	EUDAMED	Class I	Active
Smartsigns	SC1500 12HIP	EUDAMED	Class IIb	Active
Citadel Plus	FXX21A4C4AANBB	EUDAMED	Class I	Active
Sling - Loop Walking Sling	TEM-M	EUDAMED	Class I	Active
AtmosAir Velaris	633047IT	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