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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 20 of 44

Device	Model / Reference	Registries	Class	Status
Enterprise 8000x	8X23GE103BBBOA	EUDAMED	Class I	Active
Maxi Move	KMCSAN-10	EUDAMED	Class I	Active
Sonicaid	SC3/HL7EXP	EUDAMED	Class IIb	Active
AtmosAir Velaris	633027CZ	EUDAMED	Class I	Active
Maxi Sky 2	MS100-01-03	EUDAMED	Class I	Active
Maxi Sky 2	MS011-W1-08	EUDAMED	Class I	Active
Pentaflex	120PMX000/000	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X1DR112CDDAA	EUDAMED	Class I	Active
Sling - Amputee loop hammock	MLA70000L	EUDAMED	Class I	Active
Enterprise 5000x	E5X3OG116CCAAB	EUDAMED	Class I	Active
Maxi Move	KMCLXN-12	EUDAMED	Class I	Active
Evenda	EN11ABD1BSAAFA	EUDAMED	Class I	Active
Sling - Loop toilet sling – padded legs	MLA4031-XL	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X3Q0003BFAZA	EUDAMED	Class I	Active
Hydroven	510004DK	EUDAMED	Class IIa	Active
Hydroven	5103L92	EUDAMEDFDA UDI	Class IIa	Active
Nimbus	649014HR	EUDAMED	Class IIa	Active
AtmosAir Velaris	633023DE	EUDAMED	Class I	Active
AtmosAir Velaris	633016SL	EUDAMED	Class I	Active
Dopplex	ACC-VAS-007	EUDAMEDFDA UDI	Class I	Active
Sling - Bariatric loop hammock	MAA80300L	EUDAMED	Class I	Active
Sara Flex standing sling – separate belt with one buckle	TSS.501S-1C	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCSXE-00	EUDAMED	Class I	Active
Sling - Amputee clip	MAA2090M0XXL	EUDAMED	Class I	Active
Maxi Move	KMCSXN-C-09	EUDAMED	Class I	Active
Enterprise 8000x	8X24GJ033BABOA	EUDAMED	Class I	Active
Sonicaid	ACC-OBS-009L	EUDAMEDFDA UDI	Class I	Active
Sling - Clip bathing sling – unpadded legs	MAA4060M-XL	EUDAMEDFDA UDI	Class I	Active
AtmosAir Velaris	633025ES	EUDAMED	Class I	Active
Smartsigns	ACC-VSM-238	EUDAMED	Class I	Active
Maxi Move	KMCLXN-C-07	EUDAMED	Class I	Active
Minuet 2	160AA4A1A	EUDAMED	Class I	Active
Maxi Move	KMCSAE-D-15	EUDAMED	Class I	Active
Maxi Move	KMCSAE-05	EUDAMED	Class I	Active
Maxi Move	KMCEAN-05	EUDAMED	Class I	Active
AtmosAir Velaris	633021SE	EUDAMED	Class I	Active
Sling - Clip sling – padded legs	MAA4000M0XXL	EUDAMED	Class I	Active
Enterprise 5000x	E5X2HC003BEAHA	EUDAMED	Class I	Active
Enterprise 9000x	9X21AN101FCBOA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3QY103DFAZA	EUDAMED	Class I	Active
AtmosAir Velaris	633024NO	EUDAMED	Class I	Active
Enterprise 5000x	E5X3DR117CEDAA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DD101ABAAA	EUDAMED	Class I	Active
Maxi Sky 2	MS003-02-99	EUDAMED	Class I	Active
Arjo	ENT-ACC101	EUDAMED	Class I	Active
Enterprise 5000x	E5X334133BFAZA	EUDAMED	Class I	Active
AtmosAir Velaris	633031GR	EUDAMED	Class I	Active
Citadel	CXX22C4M3ALRC0	EUDAMED	Class I	Active
Enterprise 8000x	8X23GQ103BFABA	EUDAMED	Class I	Active
Sling-Bariatric loop comfort	MAA80000M	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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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