I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI
IT-MF-000028898 · Italy · Roma
I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI is registered in the European database on medical devices as a manufacturer, with 27 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: 200 pcs/pack.
Devices declared under this manufacturer
- AUTOANALYZER MOD. HEMO ONE p/n 11154-10-A
- AUTOANALYZER MOD. MIURA 200 DA (44 Rgt Pos) p/n 10997-01-A
- AUTOANALYZER MOD. MIURA DA (79 Smp Pos) p/n 10001-01-A
- Multiclean solution for Hemo One 1x1000
- Reading cuvettes Miura 200 pcs/pack
- Soluzione Rinse Ew Cvt per Miura 6x35ml
- Soluzione Rinse Ew Prb per Miura 6x15ml
- Soluzione Rinse NEW cvt per Miura 6x35ml
- Soluzione cleaner per Miura 2 Lt
- Soluzione cleaner per Miura 2x100ml
- Soluzione sistemica 20x1Lt
- Soluzione sistemica Hemo One 8x13ml
Showing 12 of 27 declared devices.
Catalogue references include I3260011206, I3320001200, I3330000001, P3140000093, P3140000252, P3140000275.
European nomenclature codes declared: W0599, W0201030101, W0503010203, W05019001.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 27 |
| 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 | 27 |
|---|---|
| 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. I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI was not found in either the U.S. or the Canadian register.