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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 14 of 44

Device	Model / Reference	Registries	Class	Status
Sling - Clip sling – padded legs	MAA4000MA-M	EUDAMED	Class I	Active
Maxi Move	KMCLAN-C-15	EUDAMED	Class I	Active
Enterprise 5000x	E5X1BA001AFBOA	EUDAMED	Class I	Active
Enterprise 5000x	E5X2PN003BBBOA	EUDAMED	Class I	Active
AtmosAir Velaris	633031ES	EUDAMED	Class I	Active
Maxi Sky 2	MS100-01-10	EUDAMED	Class I	Active
AtmosAir Velaris	633044PT	EUDAMED	Class I	Active
AtmosAir Velaris	633024IT	EUDAMED	Class I	Active
Maxi Move	KMCSAN-09	EUDAMED	Class I	Active
Enterprise 9000x	9X22BE111FABOA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3Q4113DFDBA	EUDAMED	Class I	Active
Citadel	CXX22C4T4ALMD0	EUDAMED	Class I	Active
Arjo	700-19470	EUDAMED	Class I	Active
Miranti	CEB8301-01	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DR112CADAA	EUDAMED	Class I	Active
AtmosAir Velaris	633023PL	EUDAMED	Class I	Active
AtmosAir Velaris	633017RO	EUDAMED	Class I	Active
Citadel	CX621B4R2AAAB0	EUDAMED	Class I	Active
Alpha Active 3	648305SE	EUDAMED	Class IIa	Active
Alpha Active 5	648203	EUDAMED	Class I	Active
Maxi Move	KMCSXN-11	EUDAMED	Class I	Active
Alpha Active 4	648315LV	EUDAMED	Class IIa	Active
Flowtron	526000-30	EUDAMED	Class IIa	Active
Sling - Clip sling – padded legs	MAA4000M0XL	EUDAMED	Class I	Active
Enterprise 9000x	9X21DL001FFANA	EUDAMED	Class I	Active
Sling - Clip bathing sling – unpadded legs	MAA4060M-LL	EUDAMEDFDA UDI	Class I	Active
Smartsigns	SC1500 12NI	EUDAMED	Class IIb	Active
Enterprise 9000x	9X22BA101BCAAA	EUDAMED	Class I	Active
Sling-Bariatric loop hammock sling - divided legs	MAA8020-XL	EUDAMEDFDA UDI	Class I	Active
AtmosAir Velaris	633901IS	EUDAMED	Class I	Active
Pentaflex	150SLX000/000	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X3HY113BFANA	EUDAMED	Class I	Active
Sling - Loop sling – padded legs	MLA20000XL	EUDAMED	Class I	Active
System 2000 - Primo	AP02801EU1011	EUDAMED	Class I	Active
Dopplex	VP8XS	EUDAMED	Class IIa	Active
Caylis	675002DE	EUDAMED	Class IIa	Active
Enterprise 9000x	9X22BZ111FFAZA	EUDAMED	Class I	Active
Enterprise 5000x	E5G3NQ118CDDBA	EUDAMED	Class I	Active
Enterprise 9000x	9X21DW111BAHRB	EUDAMED	Class I	Active
Enterprise 5000x	E5X1N4111CDDBA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3AL136CBAVB	EUDAMED	Class I	Active
Maxi Move	KMCSAN-D-36	EUDAMED	Class I	Active
Enterprise 9000x	9X21AJ101BEABB	EUDAMED	Class I	Active
Sling - Amputee clip	MAA2090M-L	EUDAMEDFDA UDI	Class I	Active
Maxi Sky 2	MS115-01-18	EUDAMED	Class I	Active
Flowtron	526000-07	EUDAMED	Class IIa	Active
Maxi Move	KMCSXE-D-99	EUDAMED	Class I	Active
Enterprise 5000x	E5X2QQ113BBBOA	EUDAMED	Class I	Active
Woundexpress	WE100P-EUR	EUDAMED	Class IIa	Active
Enterprise 5000x	E5X2HD103DAAAA	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