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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 25 of 44

Device	Model / Reference	Registries	Class	Status
Enterprise 9000x	9X21DY101DDABA	EUDAMED	Class I	Active
Maxi Move	KMCSAN-17	EUDAMED	Class I	Active
Nimbus	649014LT	EUDAMED	Class IIa	Active
AtmosAir Velaris	633021HU	EUDAMED	Class I	Active
Enterprise 5000x	E5X3PE003BAABA	EUDAMED	Class I	Active
Kwiktrak	200-12872	EUDAMED	Class I	Active
Enterprise 9000x	9X21DG001FCAZA	EUDAMED	Class I	Active
Smartsigns	SC1500 12HI	EUDAMED	Class IIb	Active
AtmosAir Velaris	633029LV	EUDAMED	Class I	Active
Enterprise 5000x	E5X3NN116CFDBA	EUDAMED	Class I	Active
Arjo	504029310	EUDAMED	Class I	Active
Enterprise 5000x	E5X3QG113DBDBA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DA101AAAAA	EUDAMED	Class I	Active
Enterprise 8000x	8X23HE103BDABA	EUDAMED	Class I	Active
Sonicaid	TEAM3A NM	EUDAMED	Class IIb	Active
Minstrel	HMA0007	EUDAMED	Class I	Active
Hydroven	5101L92	EUDAMEDFDA UDI	Class IIa	Active
Enterprise 8000x	8X23GE003BAABA	EUDAMED	Class I	Active
Enterprise 5000x	E5G1VQ111AFBNB	EUDAMED	Class I	Active
Concerto	BAB3102-01	EUDAMED	Class I	Active
AtmosAir Velaris	633046EN	EUDAMED	Class I	Active
AtmosAir Velaris	633027SL	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DD101AAAAA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3AA000ABBOA	EUDAMED	Class I	Active
Enterprise 5000x	E5X2FL00ABDBOA	EUDAMED	Class I	Active
Hydroven	316L84W	EUDAMEDFDA UDI	Class IIa	Active
Maxi Twin	KTBB4BSX2WW	EUDAMEDFDA UDI	Class I	Active
Enterprise 8000x	8X23GN103BEBOA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DD102AAAAA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3NQ108CFABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1OA000ABAAA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3QH113DEDAA	EUDAMED	Class I	Active
Maxi 500	KM560000	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCSAE-D-99	EUDAMED	Class I	Active
Maxi Move	KMCSAN-C-15	EUDAMED	Class I	Active
Maxi Sky 2	MS121-V1-08	EUDAMED	Class I	Active
AtmosAir Velaris	633025IT	EUDAMED	Class I	Active
Enterprise 5000x	E5X3QQ113BFABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X2HC103DAAAA	EUDAMED	Class I	Active
Maxi Sky 2	MS000-02-16	EUDAMED	Class I	Active
Maxi Move	KMCLXN-C-12	EUDAMED	Class I	Active
Enterprise 5000x	E5X3BA106CBABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3Q4113BFAZB	EUDAMED	Class I	Active
Alenti	CDB8101-01	EUDAMED	Class I	Active
Enterprise 9000x	9X22BQ101BFABA	EUDAMED	Class I	Active
Pentaflex	250SL000/000W	EUDAMEDFDA UDI	Class I	Active
Evenda	EN31AXB3KLVABCA	EUDAMED	Class I	Active
Sling - Amputee clip in situ	MAA2050M0S	EUDAMED	Class I	Active
Enterprise 5000x	E5X3FE003BFBOA	EUDAMED	Class I	Active
Sonicaid	TEAM3I B3	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