Celsius Medical S.L.
ES-MF-000006604 · Spain · Ajalvir
Celsius Medical S.L. is registered in the European database on medical devices as a manufacturer, with 68 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 52 |
|---|---|
| Class IIb | 16 |
Most frequent device types declared: CCALIMA11, CCALIMA121S, CCALIMA12S, CCALIMA2, CCALIMA21.
Among these devices, 25 are declared sterile, 16 active.
Devices declared under this manufacturer
- CALIMA
Showing 12 of 68 declared devices.
Catalogue references include CCALIMA22S, CNOCL1S, CNOPE2, CNOPT2, CNOUB1, CNULI2.
European nomenclature codes declared: T030301, V9099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 68 |
| Country of registration | Spain |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 68 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | CELSIUS MEDICAL, S.L. |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2024-08-23 |
Licence types: System (1).
Licensed under: CALIMA WARMING SYSTEM.
North American profile: Canada only. Celsius Medical S.L. holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ES25/00001195 | issued | 2030-11-17 |