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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 2 of 44

Device	Model / Reference	Registries	Class	Status
Smartsigns	SC1500 12N	EUDAMED	Class IIb	Active
Maxi Move	KMCSAE-C-11	EUDAMED	Class I	Active
AtmosAir Velaris	633022FR	EUDAMED	Class I	Active
Enterprise 5000x	E5X3PC003BFAZA	EUDAMED	Class I	Active
Enterprise 8000x	8X23GC003DBABA	EUDAMED	Class I	Active
Nimbus Professional	651001DARW	EUDAMED	Class I	Active
Enterprise 5000x	E5X1OQ131ACAHB	EUDAMED	Class I	Active
AtmosAir Velaris	633027LV	EUDAMED	Class I	Active
Sling - Clip sling – padded legs	MAA4000M-L	EUDAMEDFDA UDI	Class I	Active
AtmosAir Velaris	633025PL	EUDAMED	Class I	Active
AtmosAir Velaris	633901IT	EUDAMED	Class I	Active
Maxi Move	KMCSXN-D-10	EUDAMED	Class I	Active
Auralis	636M02N	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X3Q5003BFAZA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3AA008ABBOA	EUDAMED	Class I	Active
Maxi Move	KMCSXN-D-09	EUDAMED	Class I	Active
Enterprise 9000x	9X28G4111FFAJC	EUDAMED	Class I	Active
Minstrel	HMA0007-UK	EUDAMED	Class I	Active
Enterprise 5000x	E5X3DE107CCADA	EUDAMED	Class I	Active
Enterprise 8000x	8X23GD113BBAAA	EUDAMED	Class I	Active
AtmosAir Velaris	633047FI	EUDAMED	Class I	Active
Dopplex	D900-P	EUDAMEDFDA UDI	Class IIa	Active
Enterprise 5000x	E5X3HE103BCDBB	EUDAMED	Class I	Active
Maxi Move	KMCSAE-C-17	EUDAMED	Class I	Active
AtmosAir Velaris	633044RO	EUDAMED	Class I	Active
Hydroven	5103L66	EUDAMEDFDA UDI	Class IIa	Active
Sling - Clip bathing sling – unpadded legs	MAA4060M0S	EUDAMED	Class I	Active
Hydroven	316T78	EUDAMED	Class IIa	Active
Sling - Amputee clip sling - “hook & loop" fastener	MAA4040M0XL	EUDAMED	Class I	Active
Enterprise 9000x	9X22CY101FDABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X2EA103FCBOA	EUDAMED	Class I	Active
Maxi 500	KM560080-09	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DD102CAAAA	EUDAMED	Class I	Active
AtmosAir Velaris	633042SL	EUDAMED	Class I	Active
Maxi Twin	KTBB2ESX2WW	EUDAMEDFDA UDI	Class I	Active
Carmina	BLB2000-013	EUDAMEDFDA UDI	Class I	Active
Nimbus	649014	EUDAMED	Class IIa	Active
Enterprise 8000x	8X23WR113DEDAA	EUDAMED	Class I	Active
Enterprise 8000x	8X23GD113DAAAA	EUDAMED	Class I	Active
Maxi Move 5	KMESS0-0	EUDAMED	Class I	Active
AtmosAir Velaris	633049CZ	EUDAMED	Class I	Active
Enterprise 5000x	E5X1BQ101ABBOA	EUDAMED	Class I	Active
Maxi Move	KMCSAN-D-16	EUDAMED	Class I	Active
Enterprise 9000x	9X21AC101BBBOA	EUDAMED	Class I	Active
Maxi Sky 2	MS010-01-17	EUDAMED	Class I	Active
Enterprise 5000x	E5X3DC116EEDDB	EUDAMED	Class I	Active
Pentaflex	120PM000/000	EUDAMEDFDA UDI	Class I	Active
Simulflex	120SX000/000	EUDAMEDFDA UDI	Class I	Active
AtmosAir Velaris	633018FI	EUDAMED	Class I	Active
AtmosAir Velaris	633046FR	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