Senzime AB
SE-MF-000016903 · Sweden · Uppsala
Senzime AB is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 14 |
|---|
Most frequent device types declared: RMI-51110, SEN 2012, SEN 2010, SEN 2013, SEN 2015.
Among these devices, 2 are declared active, 2 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 | SENZIME AB (SE) · FDA 3016490024 |
| Devices in EUDAMED | 14 |
| Country of registration | Sweden |