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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 15 of 44

Device	Model / Reference	Registries	Class	Status
Enterprise 5000x	E5X2HF103DAAAA	EUDAMED	Class I	Active
Maxi Move	KMCSAE-C-05	EUDAMED	Class I	Active
AtmosAir Velaris	633031SE	EUDAMED	Class I	Active
Smartsigns	ACC-VSM-239	EUDAMED	Class I	Active
Kwiktrak	250-13041	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AA001CBBOA	EUDAMED	Class I	Active
Enterprise 8000x	8X24GD113DAAAA	EUDAMED	Class I	Active
Kwiktrak	250-12817	EUDAMED	Class I	Active
AtmosAir Velaris	633021FI	EUDAMED	Class I	Active
Maxi Sky 2	MS110-02-46	EUDAMED	Class I	Active
Enterprise 5000x	E5X1BP101ABBNA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DN101AEABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AD011ACBNB	EUDAMED	Class I	Active
Auralis	636002ES	EUDAMED	Class IIa	Active
Concerto	BAB5000-01	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X3BF006ACAZA	EUDAMED	Class I	Active
Enterprise 9000x	9X24BD101FAAAA	EUDAMED	Class I	Active
Sonicaid	TEAM3A B	EUDAMEDFDA UDI	Class IIb	Active
AtmosAir Velaris	633021SL	EUDAMED	Class I	Active
Enterprise 8000x	8X23HN103BEABA	EUDAMED	Class I	Active
Maxi Move	KMCLXN-C-46	EUDAMED	Class I	Active
AtmosAir Velaris	633042SK	EUDAMED	Class I	Active
Alpha Trancell	ALT04NL	EUDAMED	Class IIa	Active
Enterprise 8000x	8X23HR113FCDAA	EUDAMED	Class I	Active
Concerto	BAB1000-01	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCEAN-17	EUDAMED	Class I	Active
Maxi 500	KM560300-15	EUDAMED	Class I	Active
Enterprise 5000x	E5X1CC101AAABA	EUDAMED	Class I	Active
Maxi Sky 2	MS000-02-03	EUDAMED	Class I	Active
AtmosAir Velaris	633023RO	EUDAMED	Class I	Active
Auralis	636018AT	EUDAMED	Class IIa	Active
Citadel Plus	FXX21C4B4ABQBB	EUDAMED	Class I	Active
Maxi Move	KMCEAN-11	EUDAMED	Class I	Active
Maxi Sky 2	MS000-02-45	EUDAMED	Class I	Active
Lifeguard	LG50	EUDAMED	Class I	Active
Enterprise 5000x	E5X2FE103BCBOA	EUDAMED	Class I	Active
Sling - Clip in situ sling – unpadded legs	MAA2040M-XXL	EUDAMEDFDA UDI	Class I	Active
Concerto	BAB1101-01	EUDAMED	Class I	Active
Sling - Clip bathing sling – unpadded legs	MAA4060M-S	EUDAMEDFDA UDI	Class I	Active
Maxi Sky 2	MS035-02-08	EUDAMED	Class I	Active
Enterprise 5000x	E5X3N2006AGAZA	EUDAMED	Class I	Active
Enterprise 8000x	8X23PN103BDBOA	EUDAMED	Class I	Active
Maxi Move	KMCSAE-D-03	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AG001ACBOA	EUDAMED	Class I	Active
Maxi Sky 2	MS110-01-12	EUDAMED	Class I	Active
Sara Flex	HEB0100-08	EUDAMED	Class I	Active
Maxi Sky 2	MS025-A1-08	EUDAMED	Class I	Active
Concerto	BAB3000-WW	EUDAMED	Class I	Active
Sara Flex	HEB0100-98	EUDAMED	Class I	Active
Sonicaid	TEAM3A Z3	EUDAMED	Class IIb	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