XVIVO Perfusion AB
SE-MF-000018108 · Sweden · Mölndal
XVIVO Perfusion AB is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 4 |
|---|---|
| Class IIb | 1 |
Most frequent device types declared: 1.9.
Among these devices, 3 are declared sterile, 3 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 | XVIVO PERFUSION AB (SE) · FDA 3007710603 |
| Devices in EUDAMED | 5 |
| Country of registration | Sweden |