Episurf Operations AB
SE-MF-000025702 · Sweden · Stockholm
Episurf Operations AB is registered in the European database on medical devices as a manufacturer, with 164 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 152 |
|---|---|
| Class IIb | 12 |
Among these devices, 88 are declared sterile, 12 implantable.
Devices declared under this manufacturer
- Adjustment Socket
- Drilling Socket
- Epidrill
- Epidummy
- Epiguide
- Epimandrel
- Episealer Condyle Solo
- Episealer Femoral Twin
- Episealer Knee Revision Guide
- Episealer Talus
- Episealer Trochlea Solo
- Osteotomy Depth Meter
Showing 12 of 164 declared devices.
Catalogue references include 13415N, 13712N, 13715, 14115N, 44115, 51117.
European nomenclature codes declared: P091399, P091303, P090999, V901699, P090599.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | EPISURF OPERATIONS AB (SE) · FDA 3015341893 |
| Devices in EUDAMED | 164 |
| Country of registration | Sweden |
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: United States only. Episurf Operations AB is registered in the United States but was not found in the Canadian register.