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Össur Iceland ehf.

Iceland·IS-MF-000000173

Last updated June 8, 2026

Information

Country: Iceland
Address: 5, Grjótháls, Reykjavík, Iceland
Website: ossur.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +31 (0) 499 462 840
PRRC Contact: Jóhanna Valdimarsdóttir
EUDAMED SRN: IS-MF-000000173
FDA FEI Number: —
DUNS Number: —

Catalogue (11772)

Page 3 of 236

Device	Model / Reference	Registries	Class	Status
Pro-Flex® LP Torsion	PLT0829R	EUDAMED	Class I	Active
Balance™ Foot S Torsion	BST0423RBR	EUDAMED	Class I	Active
Balance™ Foot S	BSPU627LBR	EUDAMED	Class I	Active
Re-Flex Rotate™	RSFU4240	EUDAMED	Class I	Active
Hot/Cold Therapy Gel Pad	GB22R	EUDAMED	Class I	Active
LP Vari-Flex®	VLPE5252	EUDAMED	Class I	Active
Formfit® Post-Op Knee	FPOK403201I	EUDAMED	Class I	Active
Re-Flex Rotate™	RSPE3260	EUDAMED	Class I	Active
LP Vari-Flex®	VLPU4290	EUDAMED	Class I	Active
Pro-Flex® ST	PSTU123R	EUDAMED	Class I	Active
Unloader One®	B-241528712	EUDAMED	Class I	Active
LP Vari-Flex®	VLPE3300	EUDAMED	Class I	Active
Pro-Flex® Pivot	PFP0122R	EUDAMED	Class I	Active
Pro-Flex® LP	PLPU224R	EUDAMED	Class I	Active
Flex-Foot® Balance	FBPU023R	EUDAMED	Class I	Active
Pro-Flex® XC Torsion	PXT0424LBR	EUDAMED	Class I	Active
Pro-Flex® LP Torsion	PLT0430RBR	EUDAMED	Class I	Active
FSE Foot Cover	FSE026RBR	EUDAMED	Class I	Active
Flex®	FLEXPCL-XLL	EUDAMED	Class I	Active
K2 Sensation®	K2P0427R	EUDAMED	Class I	Active
Balance™ Foot S	BSPU627R	EUDAMED	Class I	Active
Pro-Flex® Terra	PTAU426LBL	EUDAMED	Class I	Active
Rebound® DUAL	B-242610005	EUDAMED	Class I	Active
Formfit® Tracker	719168	EUDAMED	Class I	Active
Comfort SCS	AK1L0W1	EUDAMED	Class I	Active
Balance™ Foot J	JBPU122RBR	EUDAMED	Class I	Active
Chopart	CHP00626	EUDAMED	Class I	Active
LP Vari-Flex®	VLPE2280LBR	EUDAMED	Class I	Active
LP Vari-Flex®	VLPE3272LBR	EUDAMED	Class I	Active
Flex-Foot Assure®	FAPU226LBR	EUDAMED	Class I	Active
Pro-Flex® Pivot	PFPU526R	EUDAMED	Class I	Active
Pro-Flex® Terra	PTA0630R	EUDAMED	Class I	Active
Re-Flex Shock™	SSPE4300LBR	EUDAMED	Class I	Active
Re-Flex Shock™	SSPU1260	EUDAMED	Class I	Active
Balance™ Foot S Torsion	BSTU828R	EUDAMED	Class I	Active
Pro-Flex® XC	PXCU324LBR	EUDAMED	Class I	Active
Iceross Seal-In® X	I-444616	EUDAMED	Class I	Active
Vari-Flex®	VFPU6280	EUDAMED	Class I	Active
Pro-Flex® LP	PLPU730LBR	EUDAMED	Class I	Active
Balance™ Foot S Torsion	BSTU628LBR	EUDAMED	Class I	Active
LP Vari-Flex®	VLPE5280LBR	EUDAMED	Class I	Active
Balance™ Foot S Torsion	BST0424LBR	EUDAMED	Class I	Active
LP Vari-Flex®	VLPE2222RBR	EUDAMED	Class I	Active
Iceross Dermo® Cushion	I-CB4622	EUDAMED	Class I	Active
Flex-Foot Assure®	FAPU124L	EUDAMED	Class I	Active
Pro-Flex® LP	PLPU127L	EUDAMED	Class I	Active
Re-Flex Rotate™	RSPU7260	EUDAMED	Class I	Active
4-Hole adapter	AJ-235100	EUDAMED	Class I	Active
Flex-Foot Assure®	FAXE223L	EUDAMED	Class I	Active
Pro-Flex® XC	PXC0725R-TRL	EUDAMED	Class I	Active

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