Artsana S.p.A.
IT-MF-000010731 · Italy · Grandate
Artsana S.p.A. is registered in the European database on medical devices as a manufacturer, with 69 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 21 |
|---|---|
| Class IIa | 48 |
Devices declared under this manufacturer
- Control Lubgel Infinity2 IT
- Control Lubgel Nature EN
- Control Lubgel Nature ES
- Control Lubgel Tropical EN
- LYCIAS COMFORT 140 DEN Miele - 2
- LYCIAS Class 140 den Nudo - 4
- LYCIAS Class 70 den Miele - 2
- LYCIAS Class 70 den Nudo - 4
- LYCIAS Comfort 140 den Nero - 5
- LYCIAS Elegance 140 den Miele - 2
- LYCIAS Elegance 140 den Nero - 2
- LYCIAS Elegance 140 den Nudo - 2
Showing 12 of 69 declared devices.
Catalogue references include 00008859000100, 00009053000040, 00009635000100, 00009736000100, 03001307100000, 03001307300000.
European nomenclature codes declared: M030405, V9099, R0599, R05010399.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 69 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 69 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ARTSANA S.P.A. |
North American profile: Canada only. Artsana S.p.A. holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CSQ001423 | issued | 2028-11-01 |