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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 41 of 44

Device	Model / Reference	Registries	Class	Status
Enterprise 9000x	9X22BG111BCCSA	EUDAMED	Class I	Active
Dopplex	ACC-VAS-009	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCLAN-18	EUDAMED	Class I	Active
Woundexpress	WE100GL	EUDAMEDFDA UDI	Class IIa	Active
Enterprise 9000x	9X22BK101DAAAA	EUDAMED	Class I	Active
Citadel Plus	FX621A4A1AAHBA	EUDAMED	Class I	Active
Alpha Active 3	648304	EUDAMED	Class IIa	Active
AtmosAir Velaris	633024EN	EUDAMED	Class I	Active
Auralis	636002GR	EUDAMED	Class IIa	Active
AtmosAir Velaris	633901PT	EUDAMED	Class I	Active
AtmosAir Velaris	633031EN	EUDAMED	Class I	Active
Enterprise 9000x	9X21AY001BCAZA	EUDAMED	Class I	Active
Maxi Move	KMCSAN-C-12	EUDAMED	Class I	Active
Maxi Sky 2	MS110-A2-99	EUDAMED	Class I	Active
Maxi Move	KMCLAN-25	EUDAMED	Class I	Active
Enterprise 5000x	E5X2HD113BCAAB	EUDAMED	Class I	Active
Sling - Loop bathing sling – unpadded legs	MLA40600L	EUDAMED	Class I	Active
Maxi Move	KMCSAN-99	EUDAMED	Class I	Active
Sling - Loop walking jacket	MAA50000S	EUDAMED	Class I	Active
Sling - Loop toilet sling – padded legs	MAA4031M-M	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X3HC133BFANB	EUDAMED	Class I	Active
Sling - Bariatric loop hammock	MAA80300M	EUDAMED	Class I	Active
Enterprise 8000x	8X23HR113BCACA	EUDAMED	Class I	Active
Sling - Clip in situ sling – unpadded legs	MAA2040M-LL	EUDAMEDFDA UDI	Class I	Active
AtmosAir Velaris	633020SK	EUDAMED	Class I	Active
Calypso	CDB6022-01	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AQ001ABBOA	EUDAMED	Class I	Active
Enterprise 8000x	8X23HC113BBADA	EUDAMED	Class I	Active
Citadel Plus	FXX21A4D1ACFBB	EUDAMED	Class I	Active
Enterprise 8000x	8X23OR113DEDAA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AL001ACAZA	EUDAMED	Class I	Active
Alpha Trancell	ALT04FR	EUDAMED	Class IIa	Active
Enterprise 8000x	8X23GQ003DEABA	EUDAMED	Class I	Active
Sling - Clip sling – padded legs	MAA4000M-M	EUDAMEDFDA UDI	Class I	Active
Smartsigns	SC1200 12NI	EUDAMED	Class IIb	Active
Enterprise 9000x	9X22GY111FFAZA	EUDAMED	Class I	Active
Enterprise 9000x	9X22BG111BEABA	EUDAMED	Class I	Active
Hydroven	5163L76	EUDAMEDFDA UDI	Class IIa	Active
Enterprise 9000x	9X22BE101AFAAB	EUDAMED	Class I	Active
Citadel	CXX21A4N2AABA0	EUDAMED	Class I	Active
Smartsigns	SC1500 5NI	EUDAMED	Class IIb	Active
AtmosAir Velaris	633029PT	EUDAMED	Class I	Active
Maxi Move	KMCSXE-08	EUDAMED	Class I	Active
Sling - Clip sling – unpadded legs	MAA2000M0XL	EUDAMED	Class I	Active
Maxi Sky 2	MS100-02-06	EUDAMED	Class I	Active
Maxi Move	KMCSXE-03	EUDAMED	Class I	Active
Symbliss Bath Chair	SYBCB001-PL	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DU101ACAZA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3BC007CBADA	EUDAMED	Class I	Active
AtmosAir Velaris	633019SK	EUDAMED	Class I	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