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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 8 of 44

Device	Model / Reference	Registries	Class	Status
Citadel Plus	FXX21A4A1AABBB	EUDAMED	Class I	Active
Dopplex	ACC-VAS-010	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X3DR117AADAA	EUDAMED	Class I	Active
Enterprise 5000x	E5X2FA003DEBOA	EUDAMED	Class I	Active
Hydroven	316TI	EUDAMED	Class IIa	Active
Maxi Move	KMCSXN-C-21	EUDAMED	Class I	Active
Maxi Sky 2	MS110-02-40	EUDAMED	Class I	Active
Enterprise 8000x	8X23HR113FABOA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3EG003BDABA	EUDAMED	Class I	Active
Sara Flex	HEB0000-18	EUDAMED	Class I	Active
Citadel Plus	FXX21C4C4AANBA	EUDAMED	Class I	Active
AtmosAir Velaris	633045NO	EUDAMED	Class I	Active
Enterprise 5000x	E5X1BC001ABBOA	EUDAMED	Class I	Active
Sling - Clip bathing sling – unpadded legs	MAA4060M0M	EUDAMED	Class I	Active
Enterprise 9000x	9X22BE111FBBOA	EUDAMED	Class I	Active
Sling - Clip sling – unpadded legs	MAA2000M-XXL	EUDAMEDFDA UDI	Class I	Active
AtmosAir Velaris	633022HU	EUDAMED	Class I	Active
AtmosAir Velaris	633029SE	EUDAMED	Class I	Active
Enterprise 9000x	9X22BU101FCBOA	EUDAMED	Class I	Active
Maxi Move	KMCSXE-D-DK	EUDAMED	Class I	Active
Enterprise 8000x	8X23HG103DAABA	EUDAMED	Class I	Active
Maxi Move	KMCSAE-D-UK	EUDAMED	Class I	Active
Enterprise 9000x	9X22FD111BBBOA	EUDAMED	Class I	Active
AtmosAir Velaris	633024DE	EUDAMED	Class I	Active
Enterprise 5000x	E5X3CQ006AFAZA	EUDAMED	Class I	Active
Citadel Plus	FXX21A6D4AAZBB	EUDAMED	Class I	Active
Alpha Trancell	ALT04LT	EUDAMED	Class IIa	Active
Typhoon	SA3B01A00BFR1	EUDAMED	Class IIa	Active
Smartsigns	ACC-VSM-237	EUDAMED	Class I	Active
Sonicaid	TEAM3A NMB	EUDAMED	Class IIb	Active
Enterprise 5000x	E5X3OY108AFAZA	EUDAMED	Class I	Active
Maxi Move	KMCSXN-D-07	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AA101AFBOA	EUDAMED	Class I	Active
Citadel Plus	FXX21C4A3AABBA	EUDAMED	Class I	Active
Enterprise 9000x	9X21DY101FDABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X2FQ113BCACB	EUDAMED	Class I	Active
Tenor	KHA1010-UK	EUDAMED	Class I	Active
Flowtron	526000-29	EUDAMED	Class IIa	Active
Maxi Sky 2	MS100-02-12	EUDAMED	Class I	Active
Enterprise 5000x	E5X3HC103BCAHB	EUDAMED	Class I	Active
Enterprise 5000x	E5X3AC006ACANA	EUDAMED	Class I	Active
Enterprise 9000x	9X21AQ111BFBOA	EUDAMED	Class I	Active
Enterprise 9000x	9X22GY101FCAZA	EUDAMED	Class I	Active
Evenda	EN21AFB2JLUAAZA	EUDAMED	Class I	Active
Citadel Plus	FXX21C6A4AMEBB	EUDAMED	Class I	Active
Enterprise 9000x	9X22BB101ADAAA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3P3103BFDAA	EUDAMED	Class I	Active
Maxi 500	700-05503-08	EUDAMED	Class I	Active
Maxi Sky 2	MS110-A1-98	EUDAMED	Class I	Active
AtmosAir Velaris	633030IT	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