Össur Iceland ehf.
IS-MF-000000173 · Iceland · Reykjavík
Össur Iceland ehf. is registered in the European database on medical devices as a manufacturer, with 14 131 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 14 131 |
|---|
Most frequent device types declared: BU00002, BU00037, BU00044, BU00045, BU00046.
Among these devices, 497 are declared active.
Devices declared under this manufacturer
- AeroFit® Seal-In
- Balance™ Foot S Torsion
- FSW Foot Cover
- Flex-Foot Assure®
- Flex-Foot® Balance
- Flex-Foot® Balance with D/P Flexion
- Iceross Dermo® Cushion
- Pro-Flex® LP Align
- Pro-Flex® Modular
- Pro-Flex® Pivot
- Pro-Flex® ST
- Pro-Flex® Terra
Showing 12 of 14 131 declared devices.
Catalogue references include AF-STFS045, B-241519712, FBP0525R, FSW029LBR, I-CB4634, PMD0225R.
European nomenclature codes declared: Y062403, Y062409, Y061209, Y062499, Y062415, Y090399.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 14 131 |
| Country of registration | Iceland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 14 131 |
|---|---|
| Found in the U.S. device database | 15 |
| Share | 0.1 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Össur Iceland ehf. was not found in either the U.S. or the Canadian register.