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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 35 of 44

Device	Model / Reference	Registries	Class	Status
Maxi Move	KMCSXN-00	EUDAMED	Class I	Active
Miranti	CEB8302-01	EUDAMED	Class I	Active
Enterprise 5000x	E5X2PD113BFANA	EUDAMED	Class I	Active
Maxi Sky 440	LE00000-BG	EUDAMED	Class I	Active
Enterprise 5000x	E5X3QM113BCAHB	EUDAMED	Class I	Active
Maxi Sky 2	MS110-01-05	EUDAMED	Class I	Active
Alenti	CDB8152-01	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DF102CAAAA	EUDAMED	Class I	Active
Sling - Loop walking jacket	MAA5000-XL	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X1DC101AAAAA	EUDAMED	Class I	Active
Sling - Loop in situ sling – padded legs	MLAAS2000-L	EUDAMEDFDA UDI	Class I	Active
Citadel Plus	FXX21C4D4AABBB	EUDAMED	Class I	Active
Enterprise 9000x	9X22BQ111BFAEA	EUDAMED	Class I	Active
AtmosAir Velaris	633020CZ	EUDAMED	Class I	Active
Dopplex	DA100PB	EUDAMEDFDA UDI	Class IIa	Active
Sling - Amputee clip in situ	MAA2050M-XL	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X1BP131CDBNB	EUDAMED	Class I	Active
Kwiktrak	200-13030	EUDAMED	Class I	Active
Auralis	636615	EUDAMEDFDA UDI	Class I	Active
Maxi Sky 2	MS020-P1-08	EUDAMED	Class I	Active
Enterprise 8000x	8X23HC113DBABA	EUDAMED	Class I	Active
Enterprise 9000x	9X22BE101BEABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3QQ113BEAZA	EUDAMED	Class I	Active
Enterprise 8000x	8X23OM113DEDAA	EUDAMED	Class I	Active
Hydroven	316J68	EUDAMED	Class IIa	Active
Maxi Sky 2	MS003-02-08	EUDAMED	Class I	Active
Maxi Move 5	KMEHSA-0	EUDAMED	Class I	Active
Citadel Plus	FXX21C4D1AABBA	EUDAMED	Class I	Active
Maxi Sky 1000	LF21000-DK	EUDAMED	Class I	Active
Sling-Bariatric loop comfort	MAA8000-XXL	EUDAMEDFDA UDI	Class I	Active
Sling - Loop sling – padded legs	MLA2000-M	EUDAMEDFDA UDI	Class I	Active
Enterprise 8000x	8X23HQ103BFAJA	EUDAMED	Class I	Active
Enterprise 9000x	9X21BB101BAAAA	EUDAMED	Class I	Active
Enterprise 5000x	E5X32J103DAABA	EUDAMED	Class I	Active
Sling - Loop toilet sling – padded legs, without head support	MLA45310L	EUDAMED	Class I	Active
Maxi Sky 2	MS105-02-98	EUDAMED	Class I	Active
Enterprise 5000x	E5X3HC113BEAHB	EUDAMED	Class I	Active
Enterprise 5000x	E5X2GA003BBBOA	EUDAMED	Class I	Active
AtmosAir Velaris	633024NL	EUDAMED	Class I	Active
Sara Combilizer	APA1000-HU	EUDAMED	Class I	Active
Enterprise 5000x	E5X1BA000ABAJA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1FB003BCAZA	EUDAMED	Class I	Active
Sara Plus standing sling – extra postural support	KKA5370-XL	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X3OC106CCADA	EUDAMED	Class I	Active
Sonicaid	SC3BED+	EUDAMED	Class IIb	Active
Enterprise 5000x	E5X1BP101ABBNB	EUDAMED	Class I	Active
Hydroven	510STD	EUDAMED	Class IIa	Active
Enterprise 9000x	9X21DN111DECSA	EUDAMED	Class I	Active
Maxi Move	KMCSXE-C-46	EUDAMED	Class I	Active
Sonicaid	SC3/SECU	EUDAMED	Class IIb	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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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