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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 3 of 44

Device	Model / Reference	Registries	Class	Status
Enterprise 5000x	E5X1DB111AABNA	EUDAMED	Class I	Active
AtmosAir Velaris	633025LV	EUDAMED	Class I	Active
Sling - Clip in situ sling – unpadded legs	MAA2040M-XL	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCSAE-D-EU	EUDAMED	Class I	Active
Alpha Active 4	648333	EUDAMED	Class I	Active
Enterprise 8000x	8X23GA003BEABA	EUDAMED	Class I	Active
Enterprise 9000x	9X22BC101FBAAB	EUDAMED	Class I	Active
Nimbus 4	650201DAR	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCSAE-D-25	EUDAMED	Class I	Active
Sara Combilizer	APA1000-FR	EUDAMED	Class I	Active
Enterprise 9000x	9X21AN011FEABB	EUDAMED	Class I	Active
Enterprise 8000x	8X23GA003BBBOA	EUDAMED	Class I	Active
Alpha Active 3	648342	EUDAMED	Class I	Active
Arjo	504028901	EUDAMED	Class I	Active
Enterprise 9000x	9X22BY101BFABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AA004ABBOA	EUDAMED	Class I	Active
Maxi Move	KMCSUN-C	EUDAMEDFDA UDI	Class I	Active
Symbliss Bath Chair	SYBCB001-PT	EUDAMED	Class I	Active
Enterprise 9000x	9X21HY111DECSA	EUDAMED	Class I	Active
Maxi Sky 2	MS010-02-03	EUDAMED	Class I	Active
Alpha Trancell	ALT04ES	EUDAMED	Class IIa	Active
Maxi Move	KMCEAN-10	EUDAMED	Class I	Active
Auralis	636T01S	EUDAMEDFDA UDI	Class I	Active
Hydroven	5103L84	EUDAMEDFDA UDI	Class IIa	Active
Auralis	636002HU	EUDAMED	Class IIa	Active
AtmosAir Velaris	633017FI	EUDAMED	Class I	Active
Enterprise 8000x	8X23OR113DFDAA	EUDAMED	Class I	Active
Hydroven	510004DE	EUDAMED	Class IIa	Active
Maxi Sky 2	MS105-02-10	EUDAMED	Class I	Active
Enterprise 8000x	8X23HN103BFABB	EUDAMED	Class I	Active
Maxi Move	KMCEAN-D-09	EUDAMED	Class I	Active
Enterprise 5000x	E5X2EL003BCAHB	EUDAMED	Class I	Active
Enterprise 5000x	E5X2FQ113BBDJB	EUDAMED	Class I	Active
Hydroven	510LI66	EUDAMEDFDA UDI	Class IIa	Active
Enterprise 5000x	E5X1BA001ABABA	EUDAMED	Class I	Active
Maxi Move	KMCSAE-D-24	EUDAMED	Class I	Active
Enterprise 5000x	E5X3BC016EBCHB	EUDAMED	Class I	Active
Citadel Plus	FXX21C4D3AMEBA	EUDAMED	Class I	Active
Enterprise 8000x	8X23GR113BEBNB	EUDAMED	Class I	Active
Maxi Move	KMCSXE-D-05	EUDAMED	Class I	Active
Sling - Amputee loop hammock	MLA7000A0L	EUDAMED	Class I	Active
Flowtron	526000-41	EUDAMED	Class IIa	Active
Sling - Amputee clip toilet	MAA2091M-L	EUDAMEDFDA UDI	Class I	Active
Enterprise 5000x	E5X2HD103BBAAA	EUDAMED	Class I	Active
AtmosAir Velaris	633900FR	EUDAMED	Class I	Active
Maxi Move	KMCEXN-99	EUDAMED	Class I	Active
Alpha Trancell Delux	ATD001DAR	EUDAMEDFDA UDI	Class I	Active
Sara Plus disposable standing sling	MFA4000	EUDAMEDFDA UDI	Class I	Active
Smartsigns	SC1200 12HIP	EUDAMED	Class IIb	Active
Maxi Move	KMCLAN-C-07	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