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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 31 of 44

Device	Model / Reference	Registries	Class	Status
Nimbus Professional	651001P	EUDAMED	Class I	Active
Enterprise 5000x	E5X3FC103BBDDB	EUDAMED	Class I	Active
Kwiktrak	700-11850	EUDAMED	Class I	Active
Enterprise 5000x	E5X3GL103BBABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3H2113BAABA	EUDAMED	Class I	Active
Enterprise 8000x	8X23HQ113BCDAA	EUDAMED	Class I	Active
Dopplex	DMX	EUDAMED	Class IIa	Active
Maxi Sky 2	MS010-A1-06	EUDAMED	Class I	Active
Enterprise 8000x	8X23VC003BAABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AS000ABBOA	EUDAMED	Class I	Active
Maxi Move	KMCSXE-D-46	EUDAMED	Class I	Active
Sling - Loop Walking Sling	TEM-L	EUDAMEDFDA UDI	Class I	Active
Alpha Active 4	648315	EUDAMED	Class IIa	Active
Sling - Clip bathing sling – padded legs	MAA4061M-L	EUDAMEDFDA UDI	Class I	Active
AtmosAir Velaris	633026ES	EUDAMED	Class I	Active
Hydroven	316L84S	EUDAMEDFDA UDI	Class IIa	Active
Enterprise 5000x	E5X3D0106ADABA	EUDAMED	Class I	Active
Maxi Move	KMCSXN-C-46	EUDAMED	Class I	Active
Enterprise 9000x	9X21DZ111DFCSA	EUDAMED	Class I	Active
Citadel Plus	FXX21C4D3ABMBB	EUDAMED	Class I	Active
Maxi Move	KMCSAE-03	EUDAMED	Class I	Active
AtmosAir Velaris	633022NL	EUDAMED	Class I	Active
Enterprise 5000x	E5X3PR013BFABA	EUDAMED	Class I	Active
Maxi Sky 2	MS010-01-16	EUDAMED	Class I	Active
AtmosAir Velaris	633031BE	EUDAMED	Class I	Active
Maxi Sky 2	MS014-01-25	EUDAMED	Class I	Active
AtmosAir Velaris	633030BE	EUDAMED	Class I	Active
Enterprise 9000x	9X22BE111BDADA	EUDAMED	Class I	Active
Sling - Loop sling – padded legs	MLA2000-XL	EUDAMEDFDA UDI	Class I	Active
AtmosAir Velaris	633021RO	EUDAMED	Class I	Active
Enterprise 5000x	E5X32R123FDBOA	EUDAMED	Class I	Active
Enterprise 9000x	9X21AR111DFADA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1BC001AABOA	EUDAMED	Class I	Active
AtmosAir Velaris	633018HU	EUDAMED	Class I	Active
Enterprise 8000x	8X23HQ113DEDAA	EUDAMED	Class I	Active
AtmosAir Velaris	633017SL	EUDAMED	Class I	Active
Maxi Sky 2	MS120-M1-08	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DD101AAAAB	EUDAMED	Class I	Active
Hydroven	510LI76	EUDAMEDFDA UDI	Class IIa	Active
Enterprise 5000x	E5X2EQ003BBBOA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3ND118CBDBA	EUDAMED	Class I	Active
Citadel Plus	FXX21C4D1AADBB	EUDAMED	Class I	Active
Enterprise 8000x	8X24GA003DABOA	EUDAMED	Class I	Active
Citadel Plus	FXX21C4A2AABBB	EUDAMED	Class I	Active
Smartsigns	SC1200 12NP	EUDAMED	Class IIb	Active
Sling - Clip bathing sling – padded legs	MAA4061M-S	EUDAMEDFDA UDI	Class I	Active
Sara Plus standing sling	KKA5120-S	EUDAMEDFDA UDI	Class I	Active
Enterprise 8000x	8X23GA103BCABA	EUDAMED	Class I	Active
AtmosAir Velaris	633900IS	EUDAMED	Class I	Active
Carino	BOC1001-01	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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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