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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 27 of 44

Device	Model / Reference	Registries	Class	Status
Sonicaid	TEAM3I ZB3	EUDAMED	Class IIb	Active
Sling - Clip bathing sling – unpadded legs	MAA4060M-XS	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCLAN-00	EUDAMED	Class I	Active
Enterprise 5000x	E5X2QA003BBBOA	EUDAMED	Class I	Active
AtmosAir Velaris	633043HU	EUDAMED	Class I	Active
AtmosAir Velaris	633049DK	EUDAMED	Class I	Active
Enterprise 5000x	E5X3BQ106AFABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X2PG003DCBOA	EUDAMED	Class I	Active
Nimbus	649014SK	EUDAMED	Class IIa	Active
Alenti	CDB8151-01	EUDAMED	Class I	Active
Sara Flex	HEB2000-24	EUDAMED	Class I	Active
Concerto	BAB2107-01	EUDAMED	Class I	Active
Maxi Move	KMCEAN-D-10	EUDAMED	Class I	Active
AtmosAir Velaris	633023EN	EUDAMED	Class I	Active
AtmosAir Velaris	633023SK	EUDAMED	Class I	Active
Maxi Sky 2	MS013-01-06	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DR111ACAJA	EUDAMED	Class I	Active
Maxi Move 5	KMESE0-0	EUDAMEDFDA UDI	Class I	Active
Smartsigns	ACC-VSM-219	EUDAMED	Class I	Active
Arjo	ENT-ACC33/1	EUDAMED	Class I	Active
Sara Flex	HEB2100-98	EUDAMED	Class I	Active
Pentaflex	250SL000/000	EUDAMEDFDA UDI	Class I	Active
Maxi Sky 2	MS100-01-18	EUDAMED	Class I	Active
Pentaflex	450PM000/000	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X3ZC003BFAJA	EUDAMED	Class I	Active
Concerto	BAB1105-01	EUDAMED	Class I	Active
Enterprise 9000x	9X24GD111DAAAA	EUDAMED	Class I	Active
Maxi Move	KMCSAE-09	EUDAMED	Class I	Active
Maxi Sky 2	MS015-02-10	EUDAMED	Class I	Active
Enterprise 9000x	9X21AQ101AFAJA	EUDAMED	Class I	Active
Citadel Plus	FXX21C6C4AKCBB	EUDAMED	Class I	Active
Sara Flex standing sling	TSS.504	EUDAMEDFDA UDI	Class I	Active
Carendo	BIB2005-01-STK	EUDAMED	Class I	Active
Enterprise 5000x	E5X3QZ113DAAZA	EUDAMED	Class I	Active
Sling - Loop sling – padded legs	MLA2000A-XL	EUDAMEDFDA UDI	Class I	Active
Citadel	CXX22C4M2AABC0	EUDAMED	Class I	Active
Citadel	CXX21C4Q1AABA0	EUDAMED	Class I	Active
Symbliss Bath Chair	SYBCS001-ES	EUDAMED	Class I	Active
Maxi Move	KMCEXN-16	EUDAMED	Class I	Active
Citadel Plus	FXX21C4C1AABBA	EUDAMED	Class I	Active
Sling - Loop sling – padded legs	MLA2000A-M	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X1BA101ABAAB	EUDAMED	Class I	Active
Sonicaid	SC3/SITE+	EUDAMED	Class IIb	Active
AtmosAir Velaris	633042BE	EUDAMED	Class I	Active
AtmosAir Velaris	633045FI	EUDAMED	Class I	Active
Maxi Sky 2	MS020-A1-98	EUDAMED	Class I	Active
Enterprise 8000x	8X24HZ113FFAHA	EUDAMED	Class I	Active
AtmosAir Velaris	633049GR	EUDAMED	Class I	Active
Miranti	CEB8101-01	EUDAMED	Class I	Active
AtmosAir Velaris	633031PL	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