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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 28 of 44

Device	Model / Reference	Registries	Class	Status
Maxi Sky 2	MS100-01-16	EUDAMED	Class I	Active
Sling-Bariatric loop comfort	MAA8000A-M	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X3QY103FCAZA	EUDAMED	Class I	Active
Calypso	CDB7021-01	EUDAMED	Class I	Active
Sara Plus	HEP1001	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X3PJ103DAABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3P2003BCAZA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3BA006CEBOA	EUDAMED	Class I	Active
AtmosAir Velaris	633030ES	EUDAMED	Class I	Active
Enterprise 5000x	E5X2FB003BCAZA	EUDAMED	Class I	Active
Auralis	636002DE	EUDAMED	Class IIa	Active
Enterprise 5000x	E5X3AC106AABOA	EUDAMED	Class I	Active
AtmosAir Velaris	633030RO	EUDAMED	Class I	Active
Maxi Move	KMCEXN-D-07	EUDAMED	Class I	Active
Nimbus Professional	651201DAR	EUDAMEDFDA UDI	Class I	Active
Enterprise 9000x	9X21AE001FBAAB	EUDAMED	Class I	Active
Maxi Move	KMCLAN-D-09	EUDAMED	Class I	Active
Enterprise 8000x	8X23O2003BAAZA	EUDAMED	Class I	Active
Enterprise 9000x	9X22BA101ACAIB	EUDAMED	Class I	Active
Evenda	EN11ABB0BLAAFA	EUDAMED	Class I	Active
AtmosAir Velaris	633043CY	EUDAMED	Class I	Active
Sara Flex standing sling	TSS.503	EUDAMEDFDA UDI	Class I	Active
AtmosAir Velaris	633022PT	EUDAMED	Class I	Active
Enterprise 5000x	E5X1BA101CABOA	EUDAMED	Class I	Active
Hydroven	510LI50	EUDAMEDFDA UDI	Class IIa	Active
Sara Flex standing sling – separate belt with one buckle	TSS.502S-1C	EUDAMEDFDA UDI	Class I	Active
Nimbus 4	650001DAR	EUDAMEDFDA UDI	Class I	Active
Flowtron - DVT	DVT40	EUDAMED	Class I	Active
Maxi Move	KMCSXN-C-10	EUDAMED	Class I	Active
Alpha Active 4	648333W	EUDAMED	Class I	Active
Sonicaid	TEAM3A	EUDAMEDFDA UDI	Class IIb	Active
Enterprise 8000x	8X23HR113DCACA	EUDAMED	Class I	Active
Maxi Sky 2	MS110-01-37	EUDAMED	Class I	Active
Enterprise 5000x	E5X2ES003BBBOA	EUDAMED	Class I	Active
Concerto	BAB2100-EU	EUDAMED	Class I	Active
AtmosAir Velaris	633042NL	EUDAMED	Class I	Active
Kwiktrak	700-12862	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DM101ACAZA	EUDAMED	Class I	Active
Alpha Trancell Delux	ATD002DAR	EUDAMEDFDA UDI	Class I	Active
Enterprise 9000x	9X21AL001BABOA	EUDAMED	Class I	Active
Enterprise 8000x	8X24GD113BAAAA	EUDAMED	Class I	Active
Maxi Sky 2	MS115-02-15	EUDAMED	Class I	Active
Sling - Clip sling – unpadded legs	MAA2000M-L	EUDAMEDFDA UDI	Class I	Active
Minuet 2	161AA4A1A	EUDAMED	Class I	Active
Enterprise 9000x	9X21EQ131DBADA	EUDAMED	Class I	Active
Enterprise 8000x	8X23O3113BNDAA	EUDAMED	Class I	Active
Sling - Loop toilet sling – padded legs	MLA4031-S	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCEAN-D-03	EUDAMED	Class I	Active
Maxi Sky 2	MS010-02-37	EUDAMED	Class I	Active
Maxi Sky 2	MS110-01-03	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