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 36 of 44

Device	Model / Reference	Registries	Class	Status
Auralis	636C01S	EUDAMEDFDA UDI	Class I	Active
Tenor	KHA1000-UK	EUDAMED	Class I	Active
Enterprise 8000x	8X23GL133BCAHA	EUDAMED	Class I	Active
Maxi Sky 2	MS005-02-98	EUDAMED	Class I	Active
Sling-Bariatric loop hammock sling - divided legs	MAA8020-M	EUDAMEDFDA UDI	Class I	Active
AtmosAir Velaris	633044HU	EUDAMED	Class I	Active
AtmosAir Velaris	633029HU	EUDAMED	Class I	Active
Enterprise 5000x	E5X3PR113DFDBA	EUDAMED	Class I	Active
AtmosAir Velaris	633024CY	EUDAMED	Class I	Active
Enterprise 5000x	E5X3PL003BBABA	EUDAMED	Class I	Active
Maxi Sky 2 Plus	MS000-10-40	EUDAMED	Class I	Active
Carevo	BAC1111-01	EUDAMEDFDA UDI	Class I	Active
Arjo	ENT-ACC34	EUDAMED	Class I	Active
Enterprise 5000x	E5X3Q4003FFAZA	EUDAMED	Class I	Active
Arjo	700-19326	EUDAMED	Class I	Active
Maxi Sky 2	MS110-02-37	EUDAMED	Class I	Active
Smartsigns	SC1500 5HI	EUDAMED	Class IIb	Active
Enterprise 5000x	E5X3FC013BBCHB	EUDAMED	Class I	Active
Evenda	EN31AXB3KMJAAVA	EUDAMED	Class I	Active
AtmosAir Velaris	633900HU	EUDAMED	Class I	Active
Maxi Sky 2	MS005-02-08	EUDAMED	Class I	Active
Enterprise 9000x	9X21AJ021BAABA	EUDAMED	Class I	Active
Enterprise 8000x	8X23GP103BEBNA	EUDAMED	Class I	Active
Flowtron	526000-08	EUDAMED	Class IIa	Active
Enterprise 5000x	E5X1DP111ABBNA	EUDAMED	Class I	Active
Arjo	ENT-ACC66	EUDAMED	Class I	Active
Maxi Move	KMCLXN-07	EUDAMED	Class I	Active
Maxi Move	KMCSAN-D-09	EUDAMED	Class I	Active
Enterprise 9000x	9X21AC001BAABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3AC006AEABA	EUDAMED	Class I	Active
Arjo	504029302	EUDAMED	Class I	Active
Iv Pole	ENT-ACC02	EUDAMED	Class I	Active
Minstrel	HMA0006-UK	EUDAMED	Class I	Active
Maxi Sky 2	MS005-02-16	EUDAMED	Class I	Active
Maxi Move	KMCSAE-D-10	EUDAMED	Class I	Active
Symbliss Bath Chair	SYBCS011-CZ	EUDAMED	Class I	Active
Arjo	504029312	EUDAMED	Class I	Active
Enterprise 5000x	E5X330133BCADA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1BC101ABBOA	EUDAMED	Class I	Active
Maxi Sky 2	MS010-01-03	EUDAMED	Class I	Active
Enterprise 9000x	9X22BR111BFADA	EUDAMED	Class I	Active
AtmosAir Velaris	633018RO	EUDAMED	Class I	Active
Maxi Move	KMCSAE-C-03	EUDAMED	Class I	Active
Maxi Sky 2	MS013-02-10	EUDAMED	Class I	Active
Maxi Sky 2	MS125-P1-98	EUDAMED	Class I	Active
Enterprise 9000x	9X21HY111FCAIB	EUDAMED	Class I	Active
Maxi Air	MAS000001-DE	EUDAMED	Class I	Active
Sling - Clip sling – unpadded legs	MAA2000M0XS	EUDAMEDFDA UDI	Class I	Active
Maxi 500	KM560300-08	EUDAMED	Class I	Active
Sling - Clip bathing in situ sling – unpadded legs	MAA2070M0XL	EUDAMEDFDA UDI	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