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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 (2192)

Page 1 of 44

Device	Model / Reference	Registries	Class	Status
System 2000 - Rhapsody	AR32811GB2001	EUDAMED	Class I	Active
Ninjo	FA1A021ECFR1	EUDAMED	Class IIa	Active
Skin IQ MCM	SIQCPST04INT2	EUDAMED	Class IIa	Active
Skin IQ 1000	SIQCPBAS1INT1	EUDAMED	Class IIa	Active
Skin IQ MCM	SIQCPSTS1INT2	EUDAMED	Class IIa	Active
Skin IQ MCM	SIQCPSTO1INT1	EUDAMED	Class IIa	Active
Skin IQ MCM	SIQCPSTS1IT	EUDAMED	Class IIa	Active
Skin IQ MCM	SIQCPSTO4INT1	EUDAMED	Class IIa	Active
Skin IQ MCM	SIQCPST04INT1	EUDAMED	Class IIa	Active
Skin IQ MCM	SIQCPST01INT2	EUDAMED	Class IIa	Active
Skin IQ MCM	SIQCPSTS1INT1	EUDAMED	Class IIa	Active
Skin IQ 1000	SIQCOBAS1BG	EUDAMED	Class IIa	Active
Skin IQ 1000	SIQCPBAS1EU	EUDAMED	Class IIa	Active
Skin IQ MCM	SIQCOSTO1INT1	EUDAMED	Class IIa	Active
Skin IQ 1000	SIQCOBA01INT1	EUDAMED	Class IIa	Active
Skin IQ MCM	SIQCOST04INT1	EUDAMED	Class IIa	Active
Skin IQ MCM	SIQCOST01INT2	EUDAMED	Class IIa	Active
Skin IQ 1000	SIQCOBA01BG	EUDAMED	Class IIa	Active
Skin IQ MCM	SIQCOSTO4INT1	EUDAMED	Class IIa	Active
Skin IQ MCM	SIQCPST04IT	EUDAMED	Class IIa	Active
Skin IQ 1000	SIQCPBAS1IT	EUDAMED	Class IIa	Active
Skin IQ MCM	SIQCPST04EU	EUDAMED	Class IIa	Active
Skin IQ MCM	SIQCOSTS1INT2	EUDAMED	Class IIa	Active
Skin IQ 1000	SIQCPBAS1BG	EUDAMED	Class IIa	Active
Skin IQ MCM	SIQCPST01IT	EUDAMED	Class IIa	Active
Skin IQ MCM	SIQCPSTS1EU	EUDAMED	Class IIa	Active
Skin IQ 1000	SIQCPBA01INT1	EUDAMED	Class IIa	Active
Flowtron	526000-10	EUDAMED	Class IIa	Active
Skin IQ 1000	SIQCPBAS1BG	EUDAMED	Class IIa	Active
Skin IQ MCM	SIQCOSTS1INT1	EUDAMED	Class IIa	Active
Flowtron	526000-09	EUDAMED	Class IIa	Active
Skin IQ 1000	SIQCOBAO1INT1	EUDAMED	Class IIa	Active
Skin IQ MCM	SIQPSST04IT	EUDAMED	Class IIa	Active
Skin IQ MCM	SIQCPST01INT1	EUDAMED	Class IIa	Active
Skin IQ MCM	SIQCOST01INT1	EUDAMED	Class IIa	Active
Skin IQ MCM	SIQCOST04INT2	EUDAMED	Class IIa	Active
Skin IQ 1000	SIQCPBA01BG	EUDAMED	Class IIa	Active
Hydroven	316AI78	EUDAMEDFDA UDI	Class IIa	Active
Sling - Amputee clip in situ	MAA2050M-LL	EUDAMEDFDA UDI	Class I	Active
Enterprise 9000x	9X22CZ101BFABA	EUDAMED	Class I	Active
Enterprise 5000x	E5X2FA003BBBOA	EUDAMED	Class I	Active
Citadel	CXX21A4U1AABA0	EUDAMED	Class I	Active
Hydroven	5103L71	EUDAMEDFDA UDI	Class IIa	Active
Enterprise 5000x	E5X1DD101ACAAA	EUDAMED	Class I	Active
Maxi Sky 2	MS103-01-06	EUDAMED	Class I	Active
Hydroven	5103A68	EUDAMEDFDA UDI	Class IIa	Active
Sling - Amputee clip toilet	MAA2091M-XL	EUDAMEDFDA UDI	Class I	Active
Smartsigns	SC1500 12N	EUDAMED	Class IIb	Active
Maxi Move	KMCSAE-C-11	EUDAMED	Class I	Active
AtmosAir Velaris	633022FR	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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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