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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 19 of 44

Device	Model / Reference	Registries	Class	Status
Sonicaid	US1	EUDAMEDFDA UDI	Class I	Active
Enterprise 8000x	8X23GW003BEABB	EUDAMED	Class I	Active
Enterprise 8000x	8X23G1113DAAAA	EUDAMED	Class I	Active
Hydroven	5103L76	EUDAMEDFDA UDI	Class IIa	Active
Citadel	CXX21A4Q2AKBA0	EUDAMED	Class I	Active
Hydroven	5101L66	EUDAMEDFDA UDI	Class IIa	Active
Maxi Move	KMCSAN-11	EUDAMED	Class I	Active
Maxi Move	KMCEXN-12	EUDAMED	Class I	Active
Hydroven	5163L84	EUDAMEDFDA UDI	Class IIa	Active
Flowtron - DVT	DVT5	EUDAMED	Class I	Active
Citadel Plus	FXX21A6A1ACFBB	EUDAMED	Class I	Active
Concerto	BAB1000-WW	EUDAMED	Class I	Active
Maxi Sky 2 Plus	MS005-10-40	EUDAMED	Class I	Active
Enterprise 5000x	E5X3OY116AFAZA	EUDAMED	Class I	Active
Sara Flex	HEB2000-36	EUDAMED	Class I	Active
Maxi Sky 2	MS000-02-40	EUDAMED	Class I	Active
Enterprise 5000x	E5X1OD101AAAAA	EUDAMED	Class I	Active
Sling - Clip sling – padded legs	MAA4000M0XS	EUDAMED	Class I	Active
Maxi Move	KMCSAN-25	EUDAMED	Class I	Active
Minstrel	HMA0011	EUDAMED	Class I	Active
Enterprise 5000x	E5X3CW116ACAJA	EUDAMED	Class I	Active
Sonicaid	TEAM3I NMB3	EUDAMED	Class IIb	Active
Maxi Sky 2	MS105-01-16	EUDAMED	Class I	Active
Enterprise 9000x	9X21HQ111FFAIB	EUDAMED	Class I	Active
Enterprise 9000x	9X22BE111BDABA	EUDAMED	Class I	Active
Maxi Move 5	KMEHLA-M	EUDAMED	Class I	Active
Sling-Bariatric loop comfort	MAA8000A-L	EUDAMEDFDA UDI	Class I	Active
Sonicaid	CT1	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X1AA002ABBOA	EUDAMED	Class I	Active
Sling - Loop toilet sling – padded legs, without head support	MLA45310S	EUDAMED	Class I	Active
Enterprise 5000x	E5X3EY003BFAZA	EUDAMED	Class I	Active
Sonicaid	SRX	EUDAMED	Class IIa	Active
AtmosAir Velaris	633023NO	EUDAMED	Class I	Active
Sara Plus	HEP2001	EUDAMED	Class I	Active
Enterprise 5000x	E5X1HD103BAAAA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DF101AAAAA	EUDAMED	Class I	Active
Maxi Move	KMCSAN-36	EUDAMED	Class I	Active
Enterprise 5000x	E5X3DQ116AEDAA	EUDAMED	Class I	Active
Maxi Sky 2	MS025-A1-98	EUDAMED	Class I	Active
Sling - Clip bathing sling – padded legs	MAA4061M0S	EUDAMED	Class I	Active
Smartsigns	SC500 NP	EUDAMED	Class IIb	Active
Sling - Clip bathing in situ sling – unpadded legs	MAA2070M-M	EUDAMEDFDA UDI	Class I	Active
AtmosAir Velaris	633046PT	EUDAMED	Class I	Active
Sonicaid	SC3/HL7IMP	EUDAMED	Class IIb	Active
Maxi Move 5	KMEHEA-0	EUDAMED	Class I	Active
Hydroven	5101L50	EUDAMEDFDA UDI	Class IIa	Active
AtmosAir Velaris	633024HU	EUDAMED	Class I	Active
Enterprise 5000x	E5X3&N033FFANB	EUDAMED	Class I	Active
Maxi Sky 2	MS010-M1-08	EUDAMED	Class I	Active
Sonicaid	TEAM3A NB	EUDAMEDFDA UDI	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