SBM SISTEMI S.R.L.
IT-MF-000026683 · Italy · Rivalta di Torino (TO)
SBM SISTEMI S.R.L. is registered in the European database on medical devices as a manufacturer, with 20 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIa | 20 |
|---|
Among these devices, 20 are declared active.
Devices declared under this manufacturer
- DEM100
- DRYEYESCAN
- DSLC200
- ES600 - TOPOGRAFO CORNEALE
- HDA-100
- IDRA
- IDRAX
- LACRYDIAG
- OS1000 - TOPOGRAFO CORNEALE
- OS1000X - TOPOGRAFO CORNEALE
- OSA
- TDE - TOPOGRAFO CORNEALE
Showing 12 of 20 declared devices.
Catalogue references include 15010, 15011, 15011X, 15015, 15016, 15018E.
European nomenclature codes declared: Z12120199, Z12120123, Z12120299.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | SBM SISTEMI SRL (IT) · FDA 3013488369 |
| Devices in EUDAMED | 20 |
| Country of registration | Italy |
⚠️ A similar name exists; we do not assert it is the same company — why.
Device-level evidence
| Devices with a numeric GTIN | 20 |
|---|---|
| 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.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
0425-MDR-030104-00 | issued | 2029-11-10 |