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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 37 of 44

Device	Model / Reference	Registries	Class	Status
Maxi Move	KMCLAN-07	EUDAMED	Class I	Active
Enterprise 8000x	8X23GQ113BEABA	EUDAMED	Class I	Active
Iv Pole	ENT-ACC07	EUDAMED	Class I	Active
Sonicaid	TEAM3A E	EUDAMEDFDA UDI	Class IIb	Active
Maxi Move	KMCLXN-C-05	EUDAMED	Class I	Active
Enterprise 5000x	E5X3BA106ABCHB	EUDAMED	Class I	Active
Enterprise 8000x	8X23OQ103DCABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3X0008CBABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3N2006ACAZA	EUDAMED	Class I	Active
Kwiktrak	200-12875	EUDAMED	Class I	Active
AtmosAir Velaris	633021CZ	EUDAMED	Class I	Active
Maxi Move	KMCSXE-C-10	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DR112CFDAA	EUDAMED	Class I	Active
Smartsigns	MP1-UNIT	EUDAMEDFDA UDI	Class IIb	Active
Sling - Clip sling – unpadded legs	MAA2000M0S	EUDAMED	Class I	Active
Maxi Move	KMCSXN-C-03	EUDAMED	Class I	Active
Enterprise 5000x	E5X3H2103BFRRA	EUDAMED	Class I	Active
AtmosAir Velaris	633021NO	EUDAMED	Class I	Active
Iv Pole	ENT-ACC89	EUDAMED	Class I	Active
Maxi Sky 2	MS100-01-40	EUDAMED	Class I	Active
AtmosAir Velaris	633047GR	EUDAMED	Class I	Active
Concerto	BAB1102-01	EUDAMED	Class I	Active
Smartsigns	ACC-VSM-215	EUDAMED	Class I	Active
AtmosAir Velaris	633018FR	EUDAMED	Class I	Active
Enterprise 5000x	E5X3YQ136AFAJA	EUDAMED	Class I	Active
Maxi Sky 2	MS015-01-10	EUDAMED	Class I	Active
Sonicaid	EM1	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X2EC003BCBOA	EUDAMED	Class I	Active
Sling - Clip sling – padded legs	MAA4000M-XL	EUDAMEDFDA UDI	Class I	Active
Sling - Clip bathing sling – unpadded legs	MAA4060M0XXL	EUDAMED	Class I	Active
Maxi Sky 2	MS010-02-46	EUDAMED	Class I	Active
Concerto	BAB1000-NL	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AB000AAAAA	EUDAMED	Class I	Active
Minuet 2	161AC4A1H	EUDAMED	Class I	Active
Easytrack	9202010	EUDAMED	Class I	Active
Enterprise 5000x	E5X3QG103BFAHB	EUDAMED	Class I	Active
Citadel Plus	FXX21C4B4AKBBB	EUDAMED	Class I	Active
Sling - Amputee clip in situ	MAA2050M0LL	EUDAMED	Class I	Active
Citadel	CXX22C6T4AAZC0	EUDAMED	Class I	Active
Maxi Sky 2	MS000-01-09	EUDAMED	Class I	Active
Maxi Sky 2	MS010-02-06	EUDAMED	Class I	Active
Enterprise 9000x	9X21AB101BAAAB	EUDAMED	Class I	Active
Maxi Move	KMCSXN-16	EUDAMED	Class I	Active
Sara Flex	HEB2000-98	EUDAMEDFDA UDI	Class I	Active
Enterprise 9000x	9X28G6111BDBND	EUDAMED	Class I	Active
AtmosAir Velaris	633900DE	EUDAMED	Class I	Active
Sara Plus standing sling – extra postural support	KKA5370-S	EUDAMEDFDA UDI	Class I	Active
Enterprise 8000x	8X23OQ113DNDAA	EUDAMED	Class I	Active
Hydroven	510004NL	EUDAMED	Class IIa	Active
Sonicaid	TEAM3A NZB	EUDAMED	Class IIb	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