FDA Registration
Active
🇮🇹 Italy
STERIS Italy S.r.l.
Reg #: 3012708860
·
FEI: 3012708860
·
Expires 2026
Products
7
Proprietary Names
10
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- STERIS Italy S.r.l.
- Registration Number
- 3012708860
- FEI Number
- 3012708860
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Via Laurentina, 169
- City
- Pomezia Roma
- Country
- IT
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 2150060
- Address
- 5960 Heisley Rd
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
US Agent
- Business Name
- STERIS Corporation
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Rd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 4687462
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Headrest, Neurosurgical | HBM | Class 1 | Neurology | No | 2025-03-09 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2025-03-09 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 2015-10-16 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2025-03-09 |
| Endoscope Maintenance System | PUP | Class 2 | Gastroenterology, Urology | No | 2024-04-04 |
| Table, Operating-Room, Ac-Powered | FQO | Class 1 | General, Plastic Surgery | No | 2025-03-09 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2025-03-09 |
Proprietary Names
Compensated single articulation headrest (HEAD02) (MG-SD, LC-FE, PM-CM)
Table Clamp (BF788, TAB841) (MG-SD, LC- FE, PM-CM)
CLEANASCOPE Liners (PM-SD)
CLEANASCOPE Advantage Cart
Catheter Extension (BF789, BF794, TAB800KT) (MG-SD, LC-FE, PM-CM)
CMAX XRAY NA JOYSTICK (BF714, TAB800JSNA) (MG-SD, LC-FE, PM-CM)
ENDODRY Storage & Drying System (PM-MF)
Tubing Sets for Reliance 6500 Series Endoscope Drying and Storage Cabinet (PY-SD, HP-MF)
Cassette Tray and Film Holder (TAB733) (MG-SD, LC-FE, PM-CM)
CMAX X-ray Table Side Rails (BF787, TAB830) (MG-SD, LC-FE, PM-CM)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility