Is this your brand? Sign in to claim ownership.
Sign in to claim this brandBrainCool AB
Sweden·SE-MF-000005547
Last updated September 17, 2026
Information
- Country
- Sweden
- Address
- Medicon Village, Lund, Sweden
- Website
- www.braincool.se
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Johan Ralf
- EUDAMED SRN
- SE-MF-000005547
- FDA FEI Number
- 3014426939
- DUNS Number
- —
Catalogue (16)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| The Cooral System | DEN210027 | FDA 510(k) | Class II | Active |
| The IQool System | K162523 | FDA 510(k) | Class II | Active |
| The IQoolTM Warm System | K180375 | FDA 510(k) | Class II | Active |
| The IQoolTM System | K232844 | FDA 510(k) | Class II | Active |
| Cooling Pad Thigh Large | BC10-0018 | EUDAMED | Class I | Active |
| Cooling Pad Head/Neck Large | BC10-0013 | EUDAMED | Class I | Active |
| Cooling Pad Torso Large | BC10-0016 | EUDAMED | Class I | Active |
| Cooling Pad Head/Neck Medium | BC10-0012 | EUDAMED | Class I | Active |
| BrainCool System | BC10-000 | EUDAMED | Class IIb | Active |
| Cooling Pad Head/Neck Small | BC10-0011 | EUDAMED | Class I | Active |
| Cooling Pad Torso Small | BC10-0014 | EUDAMED | Class I | Active |
| PolarCap HeadCap | PC10-002 | EUDAMED | Class I | Active |
| Cooling Pad Torso Medium | BC10-0015 | EUDAMED | Class I | Active |
| Cooling Pad Head/Neck X-Small | BC10-0010 | EUDAMED | Class I | Active |
| Cooling Pad Thigh Small/Medium | BC10-0017 | EUDAMED | Class I | Active |
| Cooling Pad Torso Medium/Large | BC10-0019 | EUDAMED | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.