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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 22 of 44

Device	Model / Reference	Registries	Class	Status
AtmosAir Velaris	633031SK	EUDAMED	Class I	Active
Sling - Clip sling – unpadded legs	MAA2000M-XL	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X3FJ103DAABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3FQ103BEABA	EUDAMED	Class I	Active
Alpha Trancell Delux	ATD003DAR	EUDAMEDFDA UDI	Class I	Active
Hydroven	5101L84	EUDAMEDFDA UDI	Class IIa	Active
AtmosAir Velaris	633030CZ	EUDAMED	Class I	Active
Miranti	CEB8102-01	EUDAMED	Class I	Active
AtmosAir Velaris	633046IT	EUDAMED	Class I	Active
Flowtron - Tri Pulse	TRP40	EUDAMED	Class I	Active
Sling - Clip sling – padded legs	MAA4000M-XS	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X3QC103DCAAA	EUDAMED	Class I	Active
Citadel Plus	FXX21C4B1AAABB	EUDAMED	Class I	Active
AtmosAir Velaris	633026LV	EUDAMED	Class I	Active
Citadel Plus	FXX21C4D4AKABA	EUDAMED	Class I	Active
Maxi Move	KMCLAN-15	EUDAMED	Class I	Active
Smartsigns	ACC-VSM-217	EUDAMED	Class I	Active
Enterprise 9000x	9X22BK101FCAAA	EUDAMED	Class I	Active
Citadel Plus	FXX21C4A4AKBBA	EUDAMED	Class I	Active
Enterprise 9000x	9X21EQ131DEADA	EUDAMED	Class I	Active
Easytrack	9330110	EUDAMED	Class I	Active
Maxi Sky 2	MS110-01-06	EUDAMED	Class I	Active
Maxi Move	KMCLAN-D-12	EUDAMED	Class I	Active
AtmosAir Velaris	633027NO	EUDAMED	Class I	Active
Sonicaid	FCARE3SYS/4BED	EUDAMED	Class IIb	Active
Enterprise 8000x	8X23HG103BAABA	EUDAMED	Class I	Active
Carendo	BIB2001-01	EUDAMED	Class I	Active
Smartsigns	SC300	EUDAMED	Class IIb	Active
Maxi Sky 1000	LF21009	EUDAMEDFDA UDI	Class I	Active
Enterprise 9000x	9X21AR111FEADA	EUDAMED	Class I	Active
Citadel Plus	FXX21C4C4AKHBB	EUDAMED	Class I	Active
AtmosAir Velaris	633025FR	EUDAMED	Class I	Active
Maxi Move	KMCSAN-D-00	EUDAMED	Class I	Active
Arjo	700-19311-BOX	EUDAMED	Class I	Active
Enterprise 8000x	8X24OL113BEAHB	EUDAMED	Class I	Active
AtmosAir Velaris	633028SK	EUDAMED	Class I	Active
Enterprise 9000x	9X22BC101BCBOA	EUDAMED	Class I	Active
Enterprise 9000x	9X22BL101BFABA	EUDAMED	Class I	Active
Enterprise 9000x	9X22BR111DEADA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1OQ114CCAAA	EUDAMED	Class I	Active
Dopplex	ACC179	EUDAMED	Class I	Active
AtmosAir Velaris	633028SE	EUDAMED	Class I	Active
Hydroven	316JIS68	EUDAMED	Class IIa	Active
Auralis	636002SK	EUDAMED	Class IIa	Active
Arjo	700-19301	EUDAMED	Class I	Active
Enterprise 5000x	E5X3PE113DEDBA	EUDAMED	Class I	Active
Enterprise 8000x	8X23GG103DEBOA	EUDAMED	Class I	Active
Sara Flex standing sling	TSS.500	EUDAMEDFDA UDI	Class I	Active
Enterprise 9000x	9X21DQ011BBCTB	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AA111ABBOA	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

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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