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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 24 of 44

Device	Model / Reference	Registries	Class	Status
Sling-Bariatric loop	MAA80100M	EUDAMED	Class I	Active
Sling-Bariatric loop comfort	MAA80000L	EUDAMED	Class I	Active
AtmosAir Velaris	633024SL	EUDAMED	Class I	Active
Auralis	636T01N	EUDAMEDFDA UDI	Class I	Active
Enterprise 8000x	8X23HN103BEABB	EUDAMED	Class I	Active
Maxi Sky 2	MS025-M1-08	EUDAMED	Class I	Active
Kwiktrak	200.12810	EUDAMED	Class I	Active
Nimbus	649STD	EUDAMED	Class IIa	Active
Enterprise 8000x	8X23GQ003BDABA	EUDAMED	Class I	Active
Dopplex	VP4XS	EUDAMED	Class IIa	Active
AtmosAir Velaris	633901CY	EUDAMED	Class I	Active
Enterprise 5000x	E5X3FG003BDBOA	EUDAMED	Class I	Active
Citadel Plus	FXX21C4D4ABMBB	EUDAMED	Class I	Active
Maxi Move	KMCSAN-D-07	EUDAMED	Class I	Active
Citadel	CXX22A4T4AKBC0	EUDAMED	Class I	Active
Maxi Move	KMCSAN-C-18	EUDAMED	Class I	Active
Enterprise 5000x	E5X3DH008ACAZA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3H2123BEABA	EUDAMED	Class I	Active
Dopplex	ACC-VAS-006	EUDAMED	Class I	Active
AtmosAir Velaris	633017GR	EUDAMED	Class I	Active
Enterprise 8000x	8X23GC103BCAAB	EUDAMED	Class I	Active
Maxi Sky 2	MS115-01-17	EUDAMED	Class I	Active
Enterprise 8000x	8X23HZ113DDDAA	EUDAMED	Class I	Active
Maxi Move	KMCEXN-D-10	EUDAMED	Class I	Active
Kwiktrak	700-11502	EUDAMED	Class I	Active
AtmosAir Velaris	633901GR	EUDAMED	Class I	Active
Maxi Sky 2	MS010-A2-98	EUDAMED	Class I	Active
Sling - Loop sling – padded legs	MLA2000-XXL	EUDAMEDFDA UDI	Class I	Active
Enterprise 9000x	9X26G4111FFAJC	EUDAMED	Class I	Active
Sling - Amputee clip in situ	MAA2050M0XL	EUDAMED	Class I	Active
Maxi Sky 2	MS110-A1-99	EUDAMED	Class I	Active
Auralis	636002IS	EUDAMED	Class IIa	Active
Enterprise 5000x	E5X1DY111ACADA	EUDAMED	Class I	Active
Maxi Move	KMCSAN-C-00	EUDAMED	Class I	Active
Enterprise 8000x	8X23HL113BCACA	EUDAMED	Class I	Active
Hydroven	510AI78	EUDAMEDFDA UDI	Class IIa	Active
Enterprise 9000x	9X21EQ001BCBOA	EUDAMED	Class I	Active
Arjo	504029301	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AA000AEBOA	EUDAMED	Class I	Active
Maxi Move	KMCSXN-D-25	EUDAMED	Class I	Active
Sonicaid	SC3/CLIENTCNC	EUDAMED	Class IIb	Active
AtmosAir Velaris	633022RO	EUDAMED	Class I	Active
Maxi Sky 2	MS010-A2-99	EUDAMED	Class I	Active
Maxi Move	KMCSXE-D-EU	EUDAMED	Class I	Active
Maxi Move	KMCSXN-06	EUDAMED	Class I	Active
AtmosAir Velaris	633029NL	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DR112ACDAA	EUDAMED	Class I	Active
Sling - Amputee clip sling - “hook & loop" fastener	MAA4040M-M	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X2EA003FBBOA	EUDAMED	Class I	Active
Sling - Amputee loop hammock	MLA70000XL	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