S.I.D.EM. S.p.A.
IT-MF-000029977 · Italy · Bellusco (MB)
S.I.D.EM. S.p.A. 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 IIb | 2 |
|---|---|
| Class IIa | 3 |
Most frequent device types declared: 01.57.107560-10, 01.57.32462-10, 01.57.471177-10, Multi-shot.
Among these devices, 2 are declared active, 3 with a measuring function.
Devices declared under this manufacturer
- TEE Care System
Catalogue references include 01.57.107560-10, 01.57.32462-10, 01.57.471177-10, BM-33T.
European nomenclature codes declared: Z1302, Z12011301.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 5 |
| 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 | 5 |
|---|---|
| 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. S.I.D.EM. S.p.A. was not found in either the U.S. or the Canadian register.