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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 11 of 44

Device	Model / Reference	Registries	Class	Status
Enterprise 5000x	E5X2HD103BCAAA	EUDAMED	Class I	Active
Enterprise 9000x	9X22CR111FFACB	EUDAMED	Class I	Active
Sonicaid	OP3XS	EUDAMED	Class IIa	Active
AtmosAir Velaris	633031IT	EUDAMED	Class I	Active
Enterprise 9000x	9X22FQ111BDAIA	EUDAMED	Class I	Active
Iv Pole	ENT-ACC02-SH	EUDAMED	Class I	Active
Maxi Sky 2	MS110-02-18	EUDAMED	Class I	Active
Maxi Move	KMCSAE-D-16	EUDAMED	Class I	Active
Citadel Plus	FXX21A4A1ACFBB	EUDAMED	Class I	Active
AtmosAir Velaris	633043BE	EUDAMED	Class I	Active
Arjo	ENT-ACC33/2	EUDAMED	Class I	Active
Enterprise 9000x	9X22BQ011BABOA	EUDAMED	Class I	Active
Symbliss Bath Chair	SYBCS011-ES	EUDAMED	Class I	Active
Enterprise 8000x	8X23HP103BFABB	EUDAMED	Class I	Active
Maxi Sky 2	MS100-01-37	EUDAMED	Class I	Active
Smartsigns	SC300T	EUDAMED	Class IIb	Active
AtmosAir Velaris	633024BE	EUDAMED	Class I	Active
AtmosAir Velaris	633022GR	EUDAMED	Class I	Active
Maxi Sky 2	MS010-01-39	EUDAMED	Class I	Active
Sling - Loop bathing sling – unpadded legs	MLA4060-XL	EUDAMEDFDA UDI	Class I	Active
Evenda	EN11BAB0ILJAAFA	EUDAMED	Class I	Active
Maxi Sky 2	MS000-02-10	EUDAMED	Class I	Active
Sling-Bariatric loop	MAA8010-M	EUDAMEDFDA UDI	Class I	Active
Nimbus	649012AT	EUDAMED	Class IIa	Active
Hydroven	5163L50	EUDAMEDFDA UDI	Class IIa	Active
Maxi Move	KMCLAN-D-00	EUDAMED	Class I	Active
Enterprise 9000x	9X21AG001BCAZA	EUDAMED	Class I	Active
Maxi Move	KMCSXN-08	EUDAMED	Class I	Active
Bolero	CEB6000-01	EUDAMED	Class I	Active
Maxi Sky 2	MS020-M1-08	EUDAMED	Class I	Active
Maxi Sky 2	MS000-02-12	EUDAMED	Class I	Active
Enterprise 9000x	9X21AR111BBBNB	EUDAMED	Class I	Active
Caylis	675802	EUDAMED	Class I	Active
Enterprise 5000x	E5X3FA003BCAZA	EUDAMED	Class I	Active
Maxi Move	KMCSXN-C-07	EUDAMED	Class I	Active
Maxi Move 5	KMEHLA-0	EUDAMED	Class I	Active
Sling - Clip sling – unpadded legs	MAA2000M-S	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X3QG113BCAZA	EUDAMED	Class I	Active
Sonicaid	TEAM3I Z3	EUDAMED	Class IIb	Active
Enterprise 5000x	E5G33Q113DFDBA	EUDAMED	Class I	Active
Enterprise 5000x	E5X2EA003BBBOA	EUDAMED	Class I	Active
Evenda	EN21AFB2CLBBAZA	EUDAMED	Class I	Active
Sonicaid	SR3	EUDAMED	Class IIa	Active
Sonicaid	SC3/GDT	EUDAMED	Class IIb	Active
Enterprise 8000x	8X23GE103BDABA	EUDAMED	Class I	Active
Sling - Clip sling – padded legs	MAA4000M0M	EUDAMED	Class I	Active
Enterprise 8000x	8X23GC103BBBOA	EUDAMED	Class I	Active
Enterprise 5000x	E5X2QC103BBABA	EUDAMED	Class I	Active
Sling - Amputee clip in situ	MAA2050M-L	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X3EL113DBAVB	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