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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 21 of 44

Device	Model / Reference	Registries	Class	Status
Dopplex	PA8-XS	EUDAMEDFDA UDI	Class I	Active
Dopplex	DA100B	EUDAMED	Class IIa	Active
Enterprise 8000x	8X23HQ103BFADA	EUDAMED	Class I	Active
Sonicaid	ACC-OBS-053	EUDAMEDFDA UDI	Class I	Active
Sling - Loop sling – padded legs	MLA2000-S	EUDAMEDFDA UDI	Class I	Active
Minuet 2	161AC8A1A	EUDAMED	Class I	Active
Enterprise 8000x	8X23GJ113DCDSA	EUDAMED	Class I	Active
Sling - Clip bathing in situ sling – unpadded legs	MAA2070M0M	EUDAMED	Class I	Active
Smartsigns	MP1R-UNIT	EUDAMEDFDA UDI	Class IIb	Active
AtmosAir Velaris	633042FI	EUDAMED	Class I	Active
AtmosAir Velaris	633028LV	EUDAMED	Class I	Active
AtmosAir Velaris	633900DK	EUDAMED	Class I	Active
Citadel	CXX21A4W1AAHB0	EUDAMED	Class I	Active
Sling - Paediatric clip sling	MAA4020M0XXS	EUDAMED	Class I	Active
AtmosAir Velaris	633901FR	EUDAMED	Class I	Active
Calypso	CDB6000-01	EUDAMED	Class I	Active
Hydroven	316LI84	EUDAMEDFDA UDI	Class IIa	Active
Enterprise 8000x	8X24OY113FEAHB	EUDAMED	Class I	Active
AtmosAir Velaris	633048NL	EUDAMED	Class I	Active
Citadel Plus	FXX21C4D3AMFBA	EUDAMED	Class I	Active
Maxi Sky 2	MS110-01-17	EUDAMED	Class I	Active
Enterprise 8000x	8X23HJ033BBANB	EUDAMED	Class I	Active
Enterprise 9000x	9X21CH111FEAAB	EUDAMED	Class I	Active
Arjo	ENT-ACC03	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DA111ABAAA	EUDAMED	Class I	Active
Sonicaid	TEAM3I MB	EUDAMED	Class IIb	Active
Enterprise 9000x	9X21AR111BEBNB	EUDAMED	Class I	Active
Enterprise 8000x	8X24HM003FEACB	EUDAMED	Class I	Active
Enterprise 8000x	8X23GQ103BFAHA	EUDAMED	Class I	Active
Enterprise 5000x	E5X3CQ106AFAHB	EUDAMED	Class I	Active
AtmosAir Velaris	633016RO	EUDAMED	Class I	Active
Enterprise 5000x	E5X1DG101CAAAA	EUDAMED	Class I	Active
Enterprise 9000x	9X22BL111FBBOA	EUDAMED	Class I	Active
Sling - Amputee clip sling - “hook & loop" fastener	MAA4040M0M	EUDAMED	Class I	Active
Enterprise 5000x	E5X3N2007ACAZA	EUDAMED	Class I	Active
AtmosAir Velaris	633045NL	EUDAMED	Class I	Active
Enterprise 5000x	E5X3BQ007AFAZA	EUDAMED	Class I	Active
Alpha Active 5	648201	EUDAMED	Class IIa	Active
Sonicaid	SC3SYS/8BED	EUDAMED	Class IIb	Active
Kwiktrak	700.12840-1	EUDAMED	Class I	Active
Sling - Amputee clip in situ	MAA2050M0L	EUDAMED	Class I	Active
Enterprise 9000x	9X21EQ011BABOA	EUDAMED	Class I	Active
Arjo	700-19355	EUDAMED	Class I	Active
Sling - Amputee loop hammock	MLA70000S	EUDAMED	Class I	Active
Arjo	504029501	EUDAMED	Class I	Active
Maxi Move	KMCLXN-15	EUDAMED	Class I	Active
Enterprise 9000x	9X21AL001BABVA	EUDAMED	Class I	Active
AtmosAir Velaris	633044DE	EUDAMED	Class I	Active
Enterprise 9000x	9X22BY111FBBOA	EUDAMED	Class I	Active
AtmosAir Velaris	633017DE	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