BrainCool AB
SE-MF-000005547 · Sweden · Lund
BrainCool AB is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 11 |
|---|---|
| Class IIb | 1 |
Most frequent device types declared: Cooling Pad , PolarCap HeadCap, BC10-000.
Among these devices, 1 are declared 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 | BRAINCOOL AB (SE) · FDA 3014426939 |
| Devices in EUDAMED | 12 |
| Country of registration | Sweden |