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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 4 of 44

Device	Model / Reference	Registries	Class	Status
Smartsigns	SC1500 5N	EUDAMED	Class IIb	Active
Sonicaid	ACC-OBS-052	EUDAMED	Class I	Active
Enterprise 5000x	E5X1CC004CAADA	EUDAMED	Class I	Active
Enterprise 9000x	9X22CL131BFADB	EUDAMED	Class I	Active
Easytrack	9211010	EUDAMED	Class I	Active
Symbliss Bath Chair	SYBCB001-NO	EUDAMED	Class I	Active
Sling- Clip bathing sling – padded and extended legs	MAA4160M-S	EUDAMEDFDA UDI	Class I	Active
Enterprise 8000x	8X23PQ103BFBOA	EUDAMED	Class I	Active
AtmosAir Velaris	633045DE	EUDAMED	Class I	Active
Enterprise 5000x	E5X3Q4113BFAZA	EUDAMED	Class I	Active
Concerto	BAB3000-01	EUDAMEDFDA UDI	Class I	Active
Sara Flex standing sling	TSS.501	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCEXN-17	EUDAMED	Class I	Active
Enterprise 5000x	E5X3PG003BCAZA	EUDAMED	Class I	Active
Maxi Sky 1000	LF21000-EUUK	EUDAMED	Class I	Active
AtmosAir Velaris	633026SK	EUDAMED	Class I	Active
Minuet 2	161AC3A1H	EUDAMED	Class I	Active
Enterprise 5000x	E5X3DD118AFANA	EUDAMED	Class I	Active
Alpha Active 4	648315RO	EUDAMED	Class IIa	Active
Enterprise 8000x	8X23GL103BCAHB	EUDAMED	Class I	Active
Maxi Move	KMCSAN-D-03	EUDAMED	Class I	Active
AtmosAir Velaris	633027ES	EUDAMED	Class I	Active
Enterprise 5000x	E5X3QR103BFAZA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AA100ABBOA	EUDAMED	Class I	Active
Maxi Move	KMCSAN-16	EUDAMED	Class I	Active
Dopplex	SD2-P	EUDAMEDFDA UDI	Class IIa	Active
AtmosAir Velaris	633024SE	EUDAMED	Class I	Active
Enterprise 8000x	8X23GN103DDABA	EUDAMED	Class I	Active
Maxi Move	KMCSXN-D-46	EUDAMED	Class I	Active
Sling - Loop sling – padded legs	MLA2000A0XL	EUDAMED	Class I	Active
Enterprise 5000x	E5X2FA103BBCHB	EUDAMED	Class I	Active
Sonicaid	SC3SW/40BED	EUDAMED	Class IIb	Active
Enterprise 5000x	E5X3FA003BBABA	EUDAMED	Class I	Active
Sonicaid	TEAM3I NZ3	EUDAMED	Class IIb	Active
Enterprise 8000x	8X23GY003BEABA	EUDAMED	Class I	Active
AtmosAir Velaris	633049DE	EUDAMED	Class I	Active
Enterprise 5000x	E5X1NT112AFAJA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AE000ABBOA	EUDAMED	Class I	Active
Enterprise 5000x	E5G3DQ106AFABA	EUDAMED	Class I	Active
Hydroven	5103L50	EUDAMEDFDA UDI	Class IIa	Active
Enterprise 9000x	9X21AR111DDADA	EUDAMED	Class I	Active
Dopplex	ACC-VAS-026	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCSXE-D-BE	EUDAMED	Class I	Active
AtmosAir Velaris	633022CZ	EUDAMED	Class I	Active
Hydroven	5101L76	EUDAMEDFDA UDI	Class IIa	Active
AtmosAir Velaris	633047EN	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DA111AAAAA	EUDAMED	Class I	Active
AtmosAir Velaris	633045FR	EUDAMED	Class I	Active
Lifeguard	LG20	EUDAMED	Class I	Active
Enterprise 9000x	9X22BL101FBBOA	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