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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 32 of 44

Device	Model / Reference	Registries	Class	Status
Evenda	EN31AXD3DLCAAVA	EUDAMED	Class I	Active
Evenda	EN21ABB2JLKAAZA	EUDAMED	Class I	Active
Nimbus	649010	EUDAMED	Class IIa	Active
Dopplex	ACC-VAS-028	EUDAMED	Class I	Active
Enterprise 9000x	9X22BQ111BDBOA	EUDAMED	Class I	Active
Maxi Sky 2	MS105-01-10	EUDAMED	Class I	Active
Flowtron	526000-40	EUDAMED	Class IIa	Active
Enterprise 9000x	9X22BB101BAAAA	EUDAMED	Class I	Active
Woundexpress	WE100P	EUDAMED	Class IIa	Active
Enterprise 5000x	E5X3H2113BEABA	EUDAMED	Class I	Active
Arjo	504029307	EUDAMED	Class I	Active
Arjo	504028909	EUDAMED	Class I	Active
Maxi Move	KMCSAN-D-45	EUDAMED	Class I	Active
AtmosAir Velaris	633028FI	EUDAMED	Class I	Active
Maxi Move	KMCSAE-10	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DZ111ACAJA	EUDAMED	Class I	Active
Flowtron	526000-43	EUDAMED	Class IIa	Active
AtmosAir Velaris	633025CY	EUDAMED	Class I	Active
Enterprise 5000x	E5X2EA003BEBOA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AG001ABBOA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1NL001EBBOA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3D0106AFRRA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DR112AEDAA	EUDAMED	Class I	Active
Enterprise 5000x	E5X2QD103BAAAA	EUDAMED	Class I	Active
AtmosAir Velaris	633043EN	EUDAMED	Class I	Active
Hydroven	510004EX1	EUDAMED	Class IIa	Active
AtmosAir Velaris	633027PL	EUDAMED	Class I	Active
Maxi Move 5	KMEHS0-0	EUDAMEDFDA UDI	Class I	Active
Alpha Active 5	648202	EUDAMED	Class I	Active
Maxi Move	KMCSXN-C-11	EUDAMED	Class I	Active
AtmosAir Velaris	633045HU	EUDAMED	Class I	Active
Sara Combilizer	APA1000-WW	EUDAMED	Class I	Active
Extension Strap	700-14030	EUDAMED	Class I	Active
Sling - Clip bathing sling – padded legs	MAA4061M-LL	EUDAMEDFDA UDI	Class I	Active
AtmosAir Velaris	633030SL	EUDAMED	Class I	Active
Enterprise 5000x	E5X3BC008ACBOA	EUDAMED	Class I	Active
AtmosAir Velaris	633016SK	EUDAMED	Class I	Active
Sling - Amputee clip	MAA2090M-S	EUDAMEDFDA UDI	Class I	Active
Hydroven	316L76W	EUDAMEDFDA UDI	Class IIa	Active
Citadel	CXX21C6Q4AANA0	EUDAMED	Class I	Active
Enterprise 5000x	E5X3NG116CFABA	EUDAMED	Class I	Active
Enterprise 9000x	9X21HM131FFAIB	EUDAMED	Class I	Active
Evenda	EM11CJE3CTCA2IA	EUDAMED	Class I	Active
Enterprise 5000x	E5X2PA003BBBOA	EUDAMED	Class I	Active
Maxi 500	KM560300-EUUK	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DU111ACADA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1OP104AEBNB	EUDAMED	Class I	Active
Sling - Loop toilet sling – padded legs	MAA4031M-XXL	EUDAMEDFDA UDI	Class I	Active
Enterprise 9000x	9X22GQ111DFCSA	EUDAMED	Class I	Active
Sling - Loop in situ sling – padded legs	MLAAS2000-M	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