Aurena Laboratories AB
SE-MF-000002890 · Sweden · Karlstad
Aurena Laboratories AB is registered in the European database on medical devices as a manufacturer, with 124 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 124 |
|---|
Most frequent device types declared: REF 2002, REF 2010, REF 2003, REF 2018, REF 2013.
Among these devices, 116 are declared sterile, 121 active.
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 | AURENA LABORATORIES AB (SE) · FDA 3006542993 |
| Devices in EUDAMED | 124 |
| Country of registration | Sweden |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
28620131862-04 | supplemented | 2027-10-27 |