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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 30 of 44

Device	Model / Reference	Registries	Class	Status
AtmosAir Velaris	633047DE	EUDAMED	Class I	Active
Maxi Move	KMCSXE-C-16	EUDAMED	Class I	Active
Maxi Move	KMCSXN-D-12	EUDAMED	Class I	Active
Sling - Amputee clip bathing in situ	MAA2080M0LL	EUDAMEDFDA UDI	Class I	Active
Enterprise 9000x	9X22DY111BFAZA	EUDAMED	Class I	Active
Carino	BOC1002-01	EUDAMED	Class I	Active
AtmosAir Velaris	633023IT	EUDAMED	Class I	Active
Sonicaid	8400-6919L	EUDAMEDFDA UDI	Class I	Active
Enterprise 8000x	8X23GL103BEAHA	EUDAMED	Class I	Active
AtmosAir Velaris	633049IT	EUDAMED	Class I	Active
Enterprise 9000x	9X21AR111FFADA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3EU003BEABA	EUDAMED	Class I	Active
Maxi Sky 2	MS015-02-16	EUDAMED	Class I	Active
Alpha Active 4	648315SK	EUDAMED	Class IIa	Active
Enterprise 5000x	E5X1BP101AFBNB	EUDAMED	Class I	Active
Sonicaid	SC3/SRX	EUDAMED	Class IIb	Active
Maxi Sky 2	MS100-02-10	EUDAMED	Class I	Active
Sling - Loop toilet sling – padded legs	MAA4031M-XL	EUDAMEDFDA UDI	Class I	Active
Enterprise 8000x	8X23VQ113BFAHB	EUDAMED	Class I	Active
Maxi 500	KM560380-15	EUDAMED	Class I	Active
Citadel	CXX21A4W1AKBA1	EUDAMED	Class I	Active
Maxi Move	KMCLXN-D-08	EUDAMED	Class I	Active
AtmosAir Velaris	633044SL	EUDAMED	Class I	Active
Enterprise 5000x	E5X1BA101AAABA	EUDAMED	Class I	Active
Maxi Move	KMCSXN-D-21	EUDAMED	Class I	Active
Sling - Loop toilet sling – padded legs	MAA4031M-XS	EUDAMEDFDA UDI	Class I	Active
Citadel Plus	FXX21C4D4AKBBB	EUDAMED	Class I	Active
Sling - Loop toilet sling – padded legs, without head support	MLA4531-M	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X1DR111CDBNB	EUDAMED	Class I	Active
Maxi Sky 2	MS025-L1-98	EUDAMED	Class I	Active
Sling - Loop toilet sling – padded legs, without head support	MLA4531-S	EUDAMEDFDA UDI	Class I	Active
Hydroven	316A78	EUDAMEDFDA UDI	Class IIa	Active
Enterprise 8000x	8X23GC103BCAHA	EUDAMED	Class I	Active
Enterprise 9000x	9X21AR111FEBNB	EUDAMED	Class I	Active
Sling-Bariatric loop	MAA8010-XXL	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X1NL111ACAHB	EUDAMED	Class I	Active
Auralis	636M05N	EUDAMED	Class I	Active
Concerto	BAB1100-NL	EUDAMED	Class I	Active
Enterprise 5000x	E5X3CC008CAADA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3FU113BBCHB	EUDAMED	Class I	Active
Concerto	BAB2000-01	EUDAMEDFDA UDI	Class I	Active
Maxi Sky 440	LE00000-PL	EUDAMED	Class I	Active
Minuet 2	161AC8A1ES	EUDAMED	Class I	Active
Sling - Amputee clip in situ	MAA2050M-S	EUDAMEDFDA UDI	Class I	Active
Sling - Loop toilet sling – padded legs, without head support	MLA4531-L	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCLXN-D-18	EUDAMED	Class I	Active
AtmosAir Velaris	633019LV	EUDAMED	Class I	Active
Enterprise 8000x	8X23GC103BBABA	EUDAMED	Class I	Active
Maxi Sky 2	MS010-01-11	EUDAMED	Class I	Active
Maxi Sky 2	MS010-01-18	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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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