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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 5 of 44

Device	Model / Reference	Registries	Class	Status
Maxi Sky 2	MS120-P1-98	EUDAMED	Class I	Active
AtmosAir Velaris	633024SK	EUDAMED	Class I	Active
Maxi Sky 2	MS100-02-36	EUDAMED	Class I	Active
Arjo	504028911	EUDAMED	Class I	Active
Enterprise 5000x	E5X2EY003BBBOA	EUDAMED	Class I	Active
Sara Flex	HEB2000-45	EUDAMED	Class I	Active
Enterprise 5000x	E5X2&G013DCDBA	EUDAMED	Class I	Active
RIK Fluid Overlay	VL2200E	EUDAMEDFDA UDI	Class I	Active
Enterprise 9000x	9X22BQ111FDABB	EUDAMED	Class I	Active
Enterprise 5000x	E5X3OL006CCDAA	EUDAMED	Class I	Active
Enterprise 9000x	9X22GQ131DFCSA	EUDAMED	Class I	Active
Kwiktrak	700-11620	EUDAMED	Class I	Active
Hydroven	5163L92	EUDAMEDFDA UDI	Class IIa	Active
Hydroven	316L76S	EUDAMEDFDA UDI	Class IIa	Active
Hydroven	5163A68	EUDAMEDFDA UDI	Class IIa	Active
Enterprise 5000x	E5X3NQ116CCDBA	EUDAMED	Class I	Active
Maxi Sky 2	MS110-A2-03	EUDAMED	Class I	Active
Maxi Move 5	KMEHE0-M	EUDAMEDFDA UDI	Class I	Active
Sling - Clip sling – padded legs	MAA4000M-LL	EUDAMEDFDA UDI	Class I	Active
Enterprise 9000x	9X21AQ101BFABA	EUDAMED	Class I	Active
Sonicaid	TEAM3I NZ	EUDAMED	Class IIb	Active
Concerto	BAB5000-WW	EUDAMED	Class I	Active
Enterprise 8000x	8X23TQ113BDAHB	EUDAMED	Class I	Active
Enterprise 9000x	9X28B2101FAAAC	EUDAMED	Class I	Active
Enterprise 5000x	E5X3CP103BFANB	EUDAMED	Class I	Active
Arjo	700-15695	EUDAMED	Class I	Active
Enterprise 9000x	9X22FG111FCBOA	EUDAMED	Class I	Active
Sling - Clip sling – unpadded legs	MAA2000M0M	EUDAMED	Class I	Active
Enterprise 5000x	E5X3FJ003DAABA	EUDAMED	Class I	Active
Sonicaid	TEAM3I ZB	EUDAMED	Class IIb	Active
Enterprise 5000x	E5G3DQ006ACABA	EUDAMED	Class I	Active
Enterprise 8000x	8X23HG003BFAJA	EUDAMED	Class I	Active
AtmosAir Velaris	633045CZ	EUDAMED	Class I	Active
Enterprise 9000x	9X21AE111BFCSA	EUDAMED	Class I	Active
Enterprise 8000x	8X23GC103BCANB	EUDAMED	Class I	Active
Maxi Sky 2	MS110-01-18	EUDAMED	Class I	Active
Sonicaid	ACC-OBS-008	EUDAMEDFDA UDI	Class I	Active
Sling-Bariatric loop	MAA8010-XL	EUDAMEDFDA UDI	Class I	Active
AtmosAir Velaris	633048DE	EUDAMED	Class I	Active
Maxi Sky 2	MS000-02-36	EUDAMED	Class I	Active
AtmosAir Velaris	633027CY	EUDAMED	Class I	Active
AtmosAir Velaris	633900RO	EUDAMED	Class I	Active
Enterprise 9000x	9X21DL101FCAAB	EUDAMED	Class I	Active
AtmosAir Velaris	633025RO	EUDAMED	Class I	Active
Enterprise 5000x	E5X3NG008AFAZA	EUDAMED	Class I	Active
Maxi Sky 2	MS010-02-11	EUDAMED	Class I	Active
Enterprise 9000x	9X22BR111DDADA	EUDAMED	Class I	Active
Sling - Amputee clip	MAA2090M-XXL	EUDAMEDFDA UDI	Class I	Active
Maxi Sky 2	MS110-01-08	EUDAMED	Class I	Active
Maxi Move 5	KMESL0-0	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