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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 2 of 236

Device	Model / Reference	Registries	Class	Status
Pro-Flex® XC	PXC0424L	EUDAMED	Class I	Active
Wrist Brace	317085C	EUDAMED	Class I	Active
Pro-Flex® ST	PST0929RBR	EUDAMED	Class I	Active
Balance™ Foot S Torsion	BSTU527LBR	EUDAMED	Class I	Active
Cheetah® Xplore Junior	CHX0424	EUDAMED	Class I	Active
LP Vari-Flex®	VLPE9300R	EUDAMED	Class I	Active
Iceform® Cushion	T-CL0333	EUDAMED	Class I	Active
AFO Leaf Spring	O-110127	EUDAMED	Class I	Active
Pro-Flex® Terra	PTA0123LBL	EUDAMED	Class I	Active
Vari-Flex®	VFXE3240	EUDAMED	Class I	Active
Pro-Flex® Modular	PMD0528LBR	EUDAMED	Class I	Active
Flex-Foot Assure®	FAPE219RBR	EUDAMED	Class I	Active
Balance™ Foot S Torsion	BSTU528L	EUDAMED	Class I	Active
Balance™ Foot S	BSPU126RBR	EUDAMED	Class I	Active
Pro-Flex® Pivot	PFPU224LBR	EUDAMED	Class I	Active
Pro-Flex® Pivot	PFP0222L	EUDAMED	Class I	Active
K2 Sensation®	K2PU223L	EUDAMED	Class I	Active
Pro-Flex® XC Torsion	PXTU226LBR	EUDAMED	Class I	Active
Proprio Foot®	PSXU1625LBR	EUDAMED	Class I	Active
K2 Sensation®	K2PU121RBR	EUDAMED	Class I	Active
Pro-Flex® XC	PXC0530LBR	EUDAMED	Class I	Active
LP Vari-Flex®	VLPE1220L	EUDAMED	Class I	Active
Pro-Flex® XC	PXC0428R-TRL	EUDAMED	Class I	Active
Formfit® Walker Air	A-W1000BLK	EUDAMED	Class I	Active
Iceross Dermo® Locking	I-401634	EUDAMED	Class I	Active
Knee caps	2150	EUDAMED	Class I	Active
Pro-Flex® LP	PLP0225R	EUDAMED	Class I	Active
Pro-Flex® XC	PXCU222RBR	EUDAMED	Class I	Active
Pro-Flex® XC	PXCU226R	EUDAMED	Class I	Active
LP Vari-Flex®	VLPU2300	EUDAMED	Class I	Active
Pro-Flex® Terra	PTAU925L	EUDAMED	Class I	Active
LP Vari-Flex®	VLXE3220	EUDAMED	Class I	Active
K2 Sensation®	K2P0122L	EUDAMED	Class I	Active
Formfit® Back Support	209151	EUDAMED	Class I	Active
Pro-Flex® Terra	PTA0728LBR	EUDAMED	Class I	Active
Flex-Foot Assure®	FAPE128R	EUDAMED	Class I	Active
Iceross Dermo® Cushion	I-CBW430	EUDAMED	Class I	Active
Balance™ Foot J	JBPE329R	EUDAMED	Class I	Active
Balance™ Foot S Torsion	BSTU323RBR	EUDAMED	Class I	Active
Flex-Foot® Balance	FBPU024R	EUDAMED	Class I	Active
Re-Flex Shock™	SSPE9260R	EUDAMED	Class I	Active
Balance™ Foot S	BSP0629R	EUDAMED	Class I	Active
Pro-Flex® Modular	PMD0223R-TRL	EUDAMED	Class I	Active
Balance™ Foot S	BSP0522LBR	EUDAMED	Class I	Active
Pro-Flex® XC Torsion	PXTU729R	EUDAMED	Class I	Active
Pro-Flex® XC	PXC0422RBR	EUDAMED	Class I	Active
Flex-Symes™	SLX02250	EUDAMED	Class I	Active
Iceross® Synergy Cushion	I-CW6336	EUDAMED	Class I	Active
Pro-Flex® XC	PXCU827LBR	EUDAMED	Class I	Active
Balance™ Foot S Torsion	BST0825R	EUDAMED	Class I	Active

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