Is this your brand? Sign in to claim ownership.

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 10 of 44

Device	Model / Reference	Registries	Class	Status
Maxi Sky 2	MS005-01-15	EUDAMED	Class I	Active
Citadel Plus	FXX21A6D4AAZBA	EUDAMED	Class I	Active
AtmosAir Velaris	633048PT	EUDAMED	Class I	Active
Maxi 500	KM560000-37	EUDAMED	Class I	Active
Maxi Move	KMCLXN-C-00	EUDAMED	Class I	Active
Sonicaid	EM1L	EUDAMED	Class I	Active
Conformx	150CX000/000	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCSAE-C-15	EUDAMED	Class I	Active
AtmosAir Velaris	633042EN	EUDAMED	Class I	Active
Maxi Move	KMCSXN-05	EUDAMED	Class I	Active
AtmosAir Velaris	633046CZ	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DD100AAAAA	EUDAMED	Class I	Active
Sling - Amputee loop hammock	MLA7000-XL	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X1BA101AABOA	EUDAMED	Class I	Active
Citadel	CXX21A5Q4AMBA0	EUDAMED	Class I	Active
Enterprise 8000x	8X23GW133BBDYB	EUDAMED	Class I	Active
AtmosAir Velaris	633048EN	EUDAMED	Class I	Active
Smartsigns	ACC-VSM-218	EUDAMED	Class I	Active
Sling - Loop in situ sling – padded legs	MLAAS2000-XL	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X3QZ103BCAZA	EUDAMED	Class I	Active
Pentaflex	250SLX000/000	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCSAN-D-17	EUDAMED	Class I	Active
Enterprise 8000x	8X23GL123BCAHA	EUDAMED	Class I	Active
Sara Combilizer	APA1000-TR	EUDAMED	Class I	Active
Alpha Active 3	648305CS	EUDAMED	Class IIa	Active
Maxi Sky 2	MS100-01-12	EUDAMED	Class I	Active
Maxi Move	KMCLAN-C-10	EUDAMED	Class I	Active
Nimbus	649014GR	EUDAMED	Class IIa	Active
Alpha Trancell	ALT04DK	EUDAMED	Class IIa	Active
Concerto	BAB2000-WW	EUDAMED	Class I	Active
Maxi Sky 2	MS000-01-36	EUDAMED	Class I	Active
Enterprise 8000x	8X23V2133DDDAA	EUDAMED	Class I	Active
Maxi Move	KMCSAN-C-ES	EUDAMED	Class I	Active
Enterprise 9000x	9X22BA001BFABB	EUDAMED	Class I	Active
Citadel Plus	FXX21C4B1AKABB	EUDAMED	Class I	Active
Maxi Move	KMCEAN-08	EUDAMED	Class I	Active
AtmosAir Velaris	633022DE	EUDAMED	Class I	Active
Enterprise 9000x	9X22BG011BEABA	EUDAMED	Class I	Active
Smartsigns	SC500 HTEP	EUDAMED	Class IIb	Active
Sling - Amputee clip toilet	MAA2091M0L	EUDAMED	Class I	Active
Enterprise 8000x	8X23HR113DFACA	EUDAMED	Class I	Active
Enterprise 8000x	8X23GJ003BAABB	EUDAMED	Class I	Active
Maxi Move	KMCSXN-D-06	EUDAMED	Class I	Active
Enterprise 8000x	8X23GG003BDABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X2FG003BBBOA	EUDAMED	Class I	Active
Symbliss Bath Chair	SYBCS011-NL	EUDAMED	Class I	Active
Sling - Amputee loop hammock	MLA7000-M	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCLXN-D-99	EUDAMED	Class I	Active
Enterprise 9000x	9X22CR111DACSA	EUDAMED	Class I	Active
Maxi Move	KMCLAN-C-00	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