STERIS Italy S.r.l.
IT-MF-000007606 · Italy · Pomezia
STERIS Italy S.r.l. is registered in the European database on medical devices as a manufacturer, with 166 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 145 |
|---|---|
| Class IIb | 21 |
Most frequent device types declared: Cleanascope, Cold Chemical Sterilant, Endoscope Drying Cabinet, ISACLEAN AER, Neutra Flush.
Among these devices, 2 are declared sterile, 31 active.
Devices declared under this manufacturer
- Adaspor Plus Concentrato
- Adaspor Plus M Concentrato
- Adaspor Plus Single Shot
- ENDODRY
- ENDODRY PT
- Endostore BHT
- ISACLEAN AER
- Isapor Single Shot
- NEUTRA-FLUSH
- NEUTRA-FLUSH+
- Proteazone M
- Proteazone Plus
Showing 12 of 166 declared devices.
Catalogue references include 100850K, 105156, 15761, 4008185, 550052, LARAH258.
European nomenclature codes declared: Z12011399, Z12029099, D050102, G0399, D020102, D0801.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | STERIS Italy S.r.l. (IT) · FDA 3012708860 |
| Devices in EUDAMED | 166 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 166 |
|---|---|
| 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: United States only. STERIS Italy S.r.l. is registered in the United States but was not found in the Canadian register.