Osstell AB
SE-MF-000002162 · Sweden · Göteborg
Osstell AB is registered in the European database on medical devices as a manufacturer, with 142 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 142 |
|---|
Most frequent device types declared: Single-use SmartPeg, Reusable SmartPeg, Osstell Beacon, Osstell Beacon Im, SmartPeg Mount.
Among these devices, 112 are declared sterile, 7 active, 4 with a measuring function.
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 | OSSTELL AB (SE) · FDA 3004070020 |
| Devices in EUDAMED | 142 |
| Country of registration | Sweden |