Wellspect HealthCare
SE-MF-000026271 · Sweden · Mölndal
Wellspect HealthCare is registered in the European database on medical devices as a manufacturer, with 395 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 395 |
|---|
Among these devices, 241 are declared sterile, 36 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 | Wellspect Healthcare (SE) · FDA 3009632672 |
| Devices in EUDAMED | 395 |
| Country of registration | Sweden |