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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 40 of 44

Device	Model / Reference	Registries	Class	Status
Sonicaid	8400-6919	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCEXN-08	EUDAMED	Class I	Active
Hydroven	510AI68	EUDAMEDFDA UDI	Class IIa	Active
Hydroven	5101L71	EUDAMEDFDA UDI	Class IIa	Active
Nimbus Professional	651201DARW	EUDAMED	Class I	Active
Enterprise 8000x	8X23HQ113BCACA	EUDAMED	Class I	Active
AtmosAir Velaris	633025NL	EUDAMED	Class I	Active
Enterprise 9000x	9X22BH111DEADA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3AV006ACAZA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DQ111ABABA	EUDAMED	Class I	Active
Enterprise 9000x	9X22BE101BDAKB	EUDAMED	Class I	Active
Evenda	EM12BFE3ILTAAVA	EUDAMED	Class I	Active
Citadel	CXX21A6Q4ALRA0	EUDAMED	Class I	Active
Enterprise 5000x	E5X3BL106ACAHB	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AW001ABBOA	EUDAMED	Class I	Active
Sling - Loop sling – padded legs	MLA2000A-L	EUDAMEDFDA UDI	Class I	Active
Dopplex	ACC-VAS-023	EUDAMEDFDA UDI	Class I	Active
Enterprise 9000x	9X22BR111DFADA	EUDAMED	Class I	Active
Kwiktrak	700.12860	EUDAMED	Class I	Active
Symbliss Bath Chair	SYBCS011-PT	EUDAMED	Class I	Active
Concerto	BAB1100-UK	EUDAMED	Class I	Active
Sling - Amputee clip bathing in situ	MAA2080M0L	EUDAMED	Class I	Active
Enterprise 8000x	8X23UQ133DCDSA	EUDAMED	Class I	Active
Maxi Sky 2	MS011-G1-08	EUDAMED	Class I	Active
Hydroven	510LI71	EUDAMEDFDA UDI	Class IIa	Active
AtmosAir Velaris	633001	EUDAMED	Class IIa	Active
Enterprise 9000x	9X22BR111FDADA	EUDAMED	Class I	Active
Alpha Trancell Delux	ATD001DARW	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCLAN-D-07	EUDAMED	Class I	Active
Maxi Move	KMCLXN-46	EUDAMED	Class I	Active
Sling - Amputee clip	MAA2090M-XL	EUDAMEDFDA UDI	Class I	Active
Citadel Plus	FXX21A4A1AAHBA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3ND116CDACA	EUDAMED	Class I	Active
Sling - Clip bathing sling – padded legs	MAA4061M0L	EUDAMED	Class I	Active
Arjo	700-19331	EUDAMED	Class I	Active
Enterprise 8000x	8X23GC103BBAHB	EUDAMED	Class I	Active
Enterprise 8000x	8X23GQ103DEBOA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AG000ABBOA	EUDAMED	Class I	Active
Flowtron - Tri Pulse	TRP20	EUDAMED	Class I	Active
Maxi Sky 2	MS106-01-08	EUDAMED	Class I	Active
AtmosAir Velaris	633026FI	EUDAMED	Class I	Active
Enterprise 5000x	E5X2HR113DFACA	EUDAMED	Class I	Active
Evenda	EN11AXD1QSPABDA	EUDAMED	Class I	Active
Nimbus Professional	651001DAR	EUDAMEDFDA UDI	Class I	Active
Sling - Loop toilet sling – padded legs	MAA4031M0XS	EUDAMEDFDA UDI	Class I	Active
Auralis	636002CZ	EUDAMED	Class IIa	Active
Symbliss Bath Chair	SYBCB001-DE	EUDAMED	Class I	Active
Maxi Move	KMCEXN-06	EUDAMED	Class I	Active
Enterprise 5000x	E5X2HD103BCAZA	EUDAMED	Class I	Active
Sling - Clip bathing sling – padded legs	MAA4061M-XL	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