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: BC10-000, Cooling Pad, PolarCap HeadCap.
Among these devices, 1 are declared active.
Devices declared under this manufacturer
- BrainCool System
- Cooling Pad Head/Neck Small
- Cooling Pad Head/Neck Large
- Cooling Pad Head/Neck Medium
- Cooling Pad Head/Neck X-Small
- Cooling Pad Thigh Large
- Cooling Pad Thigh Small/Medium
- Cooling Pad Torso Large
- Cooling Pad Torso Medium
- Cooling Pad Torso Medium/Large
- Cooling Pad Torso Small
- PolarCap HeadCap
Catalogue references include BC10-000, BC10-0011, BC10-0013, BC10-0014, BC10-0015, BC10-0016.
European nomenclature codes declared: M9001.
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 |
Device-level evidence
| Devices with a numeric GTIN | 12 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. BrainCool AB is registered in the United States but was not found in the Canadian register.