Labomar S.p.A.
IT-MF-000007965 · Italy · Istrana
Labomar S.p.A. is registered in the European database on medical devices as a manufacturer, with 274 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 34 |
|---|---|
| Class IIa | 238 |
| Class I | 2 |
Among these devices, 2 are declared sterile.
Devices declared under this manufacturer
- ARGOTIAB Rapid hydrogel 25 ml PL
- Acidità e reflusso. IT
- Aspi NATURA Kids Throat Spray TR
- Bisolnatural 2 em 1 sem açúcar 100 ml PT
- Bisolnatural 3 in 1 100 ml SE, FI
- Furaderm® Stopia 30 ml ES
- GRANIONS Dermatologie_Crème ECZEMA ATOPIQUE 30 ml FR
- Helenvita Cold & Flu Cough Syrup Kids 120 ml GR
- NeoBorocillina Gola Junior Spray Gola 20 ml IT
- SOBREPIN GOLA SPRAY IT
- Stomaxil Lax ES
- Stomaxil Reflujo y Acidez IT
Showing 12 of 274 declared devices.
Catalogue references include FTP042, FTP068, FTP078, FTP080, FTP100, FTPR101.
European nomenclature codes declared: V9017, G0401, V9099, U0803, G05, G0499.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 274 |
| 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 | 123 |
|---|---|
| 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. Labomar S.p.A. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
EPT 0477.MDR.26/6216 | issued | 2028-06-14 |
CSQ0026240724 | supplemented | 2029-10-27 |