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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 7 of 44

Device	Model / Reference	Registries	Class	Status
Enterprise 5000x	E5X3FG103BABOA	EUDAMED	Class I	Active
Sara Combilizer	APA1000-BE	EUDAMED	Class I	Active
AtmosAir Velaris	633044SE	EUDAMED	Class I	Active
Enterprise 8000x	8X23GN103BDAKB	EUDAMED	Class I	Active
Smartsigns	SC500 HT	EUDAMED	Class IIb	Active
Enterprise 5000x	E5X1BQ001ABABB	EUDAMED	Class I	Active
AtmosAir Velaris	633024ES	EUDAMED	Class I	Active
Minuet 2	160AC1A1G	EUDAMED	Class I	Active
Enterprise 9000x	9X21AG101FFBOA	EUDAMED	Class I	Active
Sonicaid	TEAM3A ZB	EUDAMED	Class IIb	Active
Citadel	CXX22C4M1AABC0	EUDAMED	Class I	Active
Enterprise 8000x	8X23GQ003BAAKB	EUDAMED	Class I	Active
Maxi Move 5	KMESE0-M	EUDAMEDFDA UDI	Class I	Active
Enterprise 8000x	8X23HQ003BFABA	EUDAMED	Class I	Active
Kwiktrak	700.12850	EUDAMED	Class I	Active
Enterprise 8000x	8X23GL003BBAHB	EUDAMED	Class I	Active
Sling - Loop toilet sling – padded legs	MAA4031M0LL	EUDAMED	Class I	Active
Caylis	675800	EUDAMED	Class I	Active
Citadel Plus	FXX21C4D4AKDBA	EUDAMED	Class I	Active
Maxi 500	KM560000-08	EUDAMED	Class I	Active
AtmosAir Velaris	633016LV	EUDAMED	Class I	Active
Maxi Sky 2	MS025-Q1-98	EUDAMED	Class I	Active
Maxi 500	KM560080-08	EUDAMED	Class I	Active
Hydroven	5101A68	EUDAMEDFDA UDI	Class IIa	Active
Enterprise 5000x	E5X1DE101CAAAA	EUDAMED	Class I	Active
Citadel Plus	FXX21C4A1AABBA	EUDAMED	Class I	Active
Auralis	636M02S	EUDAMEDFDA UDI	Class I	Active
Hydroven	5163A78	EUDAMEDFDA UDI	Class IIa	Active
Sling - Loop in situ sling – padded legs	MLAAS20000M	EUDAMED	Class I	Active
Maxi Air	MAS000001-NO	EUDAMED	Class I	Active
Dopplex	ACC-VAS-027	EUDAMEDFDA UDI	Class I	Active
Maxi Sky 2	MS015-02-08	EUDAMED	Class I	Active
Maxi Sky 2	MS003-01-99	EUDAMED	Class I	Active
Dopplex	VP10XS	EUDAMED	Class IIa	Active
AtmosAir Velaris	633048BE	EUDAMED	Class I	Active
Citadel Plus	FXX21C4D3AABBB	EUDAMED	Class I	Active
AtmosAir Velaris	633030SE	EUDAMED	Class I	Active
Maxi Sky 2	MS100-01-19	EUDAMED	Class I	Active
Alpha Active 4	648314	EUDAMED	Class IIa	Active
Maxi Move	KMCSAN-03	EUDAMED	Class I	Active
Enterprise 5000x	E5X3DG006ACBOA	EUDAMED	Class I	Active
Enterprise 8000x	8X23V5103DEADA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3OQ116CADBA	EUDAMED	Class I	Active
Enterprise 8000x	8X23GL003BEABA	EUDAMED	Class I	Active
Minstrel	HMA0011-UK	EUDAMED	Class I	Active
Enterprise 8000x	8X23HQ103BCABA	EUDAMED	Class I	Active
Sara Flex	HEB2000-10	EUDAMED	Class I	Active
Sara Flex	HEB2000-19	EUDAMED	Class I	Active
Carmina Basic	BLB1000-013	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X3PH113DFDBA	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