Is this your brand? Sign in to claim ownership.

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 43 of 44

Device	Model / Reference	Registries	Class	Status
Maxi Move	KMCSAN-D-25	EUDAMED	Class I	Active
Auralis	636002PL	EUDAMED	Class IIa	Active
Citadel	CXX21C4W4AABA0	EUDAMED	Class I	Active
Smartsigns	SC500 HEP	EUDAMED	Class IIb	Active
Hydroven	316JIB	EUDAMED	Class IIa	Active
Sling - Amputee clip	MAA2090M-M	EUDAMEDFDA UDI	Class I	Active
Enterprise 9000x	9X22CY111BFANB	EUDAMED	Class I	Active
AtmosAir Velaris	633017SE	EUDAMED	Class I	Active
Enterprise 5000x	E5X2FL103BFAHB	EUDAMED	Class I	Active
Sara Combilizer	APA1000-GR	EUDAMED	Class I	Active
Maxi Move	KMCLXN-D-06	EUDAMED	Class I	Active
Enterprise 5000x	E5X3FG103DEABA	EUDAMED	Class I	Active
Maxi Move	KMCSXE-D-25	EUDAMED	Class I	Active
Pentaflex	250PM000/000	EUDAMEDFDA UDI	Class I	Active
Enterprise 9000x	9X22CD111BAAAB	EUDAMED	Class I	Active
Hydroven	316JIF	EUDAMEDFDA UDI	Class IIa	Active
Maxi Move	KMCSAN-C-25	EUDAMED	Class I	Active
AtmosAir Velaris	633031DK	EUDAMED	Class I	Active
Auralis	636002EE	EUDAMED	Class IIa	Active
Maxi Twin	KTBB4BSA2WW	EUDAMED	Class I	Active
Maxi Move	KMCLAN-D-15	EUDAMED	Class I	Active
Sling - Amputee clip sling - “hook & loop" fastener	MAA4040M-XL	EUDAMEDFDA UDI	Class I	Active
Maxi Move	KMCSAE-D-09	EUDAMED	Class I	Active
AtmosAir Velaris	633047RO	EUDAMED	Class I	Active
Enterprise 5000x	E5X3DH117CEDAA	EUDAMED	Class I	Active
AtmosAir Velaris	633019HU	EUDAMED	Class I	Active
Enterprise 9000x	9X22BR111BDADA	EUDAMED	Class I	Active
Sling - Clip sling – padded legs	MAA4000MA-L	EUDAMED	Class I	Active
Sara Combilizer	APA1000-SL	EUDAMED	Class I	Active
Enterprise 8000x	8X23HJ003BCABA	EUDAMED	Class I	Active
Maxi Sky 2	MS015-02-12	EUDAMED	Class I	Active
Maxi Sky 2	MS010-B1-08	EUDAMED	Class I	Active
Maxi Move	KMCSXN-D-UK	EUDAMED	Class I	Active
Enterprise 5000x	E5X3BG008ACAZA	EUDAMED	Class I	Active
Citadel Plus	FXX21C6C2AKZBB	EUDAMED	Class I	Active
Auralis	636614	EUDAMEDFDA UDI	Class I	Active
Hydroven	316AI68	EUDAMEDFDA UDI	Class IIa	Active
Sling - Amputee clip in situ	MAA2050M-M	EUDAMEDFDA UDI	Class I	Active
Alpha Trancell	ALT04SV	EUDAMED	Class IIa	Active
Sonicaid	TEAM3I NZB	EUDAMED	Class IIb	Active
Citadel Plus	FXX21C4D3AAABB	EUDAMED	Class I	Active
Enterprise 5000x	E5X3PF003DCAJA	EUDAMED	Class I	Active
Citadel Plus	FXX21A4A4AKBAB	EUDAMED	Class I	Active
Minuet 2	160AC2A1F	EUDAMED	Class I	Active
Enterprise 5000x	E5X32J003DCABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X1AC111ABAZA	EUDAMED	Class I	Active
Maxi Sky 2	MS000-01-17	EUDAMED	Class I	Active
Enterprise 8000x	8X23HG003FCAZA	EUDAMED	Class I	Active
Maxi Sky 2	MS110-A1-06	EUDAMED	Class I	Active
Maxi Twin Compact	KTCB4BSX2WW	EUDAMEDFDA UDI	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