SOL GROUP LAB S.r.l.
IT-MF-000025276 · Italy · Costabissara
SOL GROUP LAB S.r.l. is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 6 |
|---|---|
| Class IIb | 2 |
Among these devices, 4 are declared active, 2 with a measuring function.
Devices declared under this manufacturer
- EMONO
- EMONO trolley
- PENELOPE MANUAL DOSING EMERGENCY KIT
- geaNOx
- geaNOx trolley
- iNO flextube
- penelope 2.0
- penelope trolley
Catalogue references include EM080CA01, EM1100CA, EM1101CA, EM1103IM, EM1104IM, EM140IM.
European nomenclature codes declared: Z1203019002, Z1203019099, Z1203019080.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 8 |
| 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 | 8 |
|---|---|
| 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: Neither register. SOL GROUP LAB S.r.l. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
0425-MDR-030142-00 | issued | 2030-07-31 |