SWAN MEDICAL, S.L
ES-MF-000001526 · Spain · Barcelona
SWAN MEDICAL, S.L is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 5 |
|---|
Among these devices, 4 are declared sterile.
Devices declared under this manufacturer
- RUTILIGHT
- Rutiside
Catalogue references include FA-RL01, RL-01, RS-01.
European nomenclature codes declared: K0299, Z12020499.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 5 |
| 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 | 5 |
|---|---|
| Found in the U.S. device database | 3 |
| Share | 60.0 % |
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SWAN MEDICAL S.L. |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2021-11-09 |
Licence types: Device Family (1).
Licensed under: RUTILIGHT.
North American profile: Canada only. SWAN MEDICAL, S.L holds a Canadian licence but was not found in the U.S. register.