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.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
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 |